Tag Archives: Research

New pharmaceutical product to prevent heroin deaths

A new, lifesaving product aimed at reducing the death toll from heroin abuse — developed by a professor at the University of Kentucky College of Pharmacy — is in its final round of clinical trials and has received Fast Track designation by the Food and Drug Administration.

The product, a nasal spray application of the anti-opioid drug naloxone, was developed by Daniel Wermeling, UK professor of pharmacy practice and science, through his startup company AntiOp Inc.

Naloxone is the standard treatment for suspected opioid overdose, already in use by emergency rooms and emergency medical technicians across the country. Opioids are the class of pain-killing drugs that are related to morphine, including prescription drugs such as hydrocodone and oxycodone, as well as illegal drugs such as heroin.
Currently, naloxone is administered by injection. The nasal spray eliminates the need for needles, with a ready-to-use, single-use delivery device inserted into the nose of an overdose victim. The product delivers a consistent dose, absorbed across the nasal membranes even if the patient is not breathing.

“The goal is to make the medication available to patients at high risk of opioid overdose, and to caregivers, including family members, who may lack specialized medical training,” Wermeling said. “The treatment could be given in anticipation of EMS arrival, advancing the continuum of care and ultimately saving lives.”

Nationwide, deaths from opioid overdose are on the rise, according to data from the Centers for Disease Control and Prevention. Kentucky, long troubled by widespread abuse of prescription opioids, has seen a dramatic rise in deaths from heroin overdose in recent years. In autopsies from 2013, the state medical examiner attributed 230 deaths to heroin overdose, an increase of more than 60 percent from the previous year.

UK President Eli Capilouto congratulated Wermeling on his success with AntiOp, saying that it reflects the core values of the university.

“Too many Kentucky families have experienced the tragedy of seeing a loved one’s life cut short by a drug overdose,” Capilouto said. “The epidemic of opioid abuse in our state presents an enormous and urgent challenge, not only for health care providers and law enforcement, but also for us here at the University of Kentucky. Dr. Wermeling’s project is putting a powerful new tool into the hands of those on the front line of the fight against heroin, both here in Kentucky and beyond. This type of innovation embodies the three main components of the university’s mission — education, research and, above all, service.”

UK College of Pharmacy Dean Timothy S. Tracy said Wermeling’s work also provides an illustration of “bench-to-bedside” research in action. “Dr. Wermeling’s project is a great example of how UK College of Pharmacy faculty are working each and every day to create healthier Kentucky communities,” Tracy said. “Dr. Wermeling and his collaborative team of research colleagues saw a problem facing families in Kentucky and across the nation and developed an innovative solution. That type of translational approach is important to our college, this university, and, of course, the future of our Commonwealth.”

Wermeling’s research was supported by a three-year, $3 million grant from the National Institutes of Health through the National Institute on Drug Abuse with additional funding from the Kentucky Science and Technology Corporation. In May, AntiOp partnered with Reckitt Benckiser Pharmaceuticals to accelerate production and worldwide marketing of intranasal naloxone.

The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
“As an educator, pharmacist, researcher and entrepreneur, being able to work on this naloxone project has been a dream come true,” Wermeling said. “I often tell my students and colleagues that this project has allowed me to use all of the skills I have learned over the years. It has been the ultimate problem-solving project, requiring me to utilize my pharmacological skills, my drug delivery knowledge, my business and marketing skills — all at the same time.

“At the end of the day, however, this project has always been about people. It has always been about utilizing the knowledge and skills that we have to improve patient care.”

A video featuring Dr. Wermeling discussing this work may be viewed online at https://www.youtube.com/watch?v=pgjIH5KkH0k

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Snail Venom Has Potential to Create Powerful New Painkillers

Though still in the research phase, the venom-filled treatment could produce a new class of drugs one hundred times more powerful than morphine.

Ocean-dwelling cone snails have become responsible for one of the most powerful drugs on the planet. Australian researchers have created a drug using venom from cone snails that is reportedly 100 times more powerful than morphine and “appeared to significantly reduce pain.”

The Sydney Morning Herald has noted that the still-unnamed drug doesn’t have the addictive components of other painkillers. The primary ingredient in the drug is conotoxin, a compound secreted by cone snails.

But as of now, it has only been tested on rats and a human trial is still two years away. “We don’t know about side effects yet, as it hasn’t been tested in humans. But we think it would be safe,” said lead researcher David Craik of the University of Queensland in Australia. The goal of the drug is to manage neuropathic pain, which affects 15 percent of the U.S. population and can arise from cancer, AIDS, diabetes, and other debilitating diseases.

Craik thinks that the venom-filled treatment could open up a “whole new class of drugs capable of relieving one of the most severe forms of chronic pain that is currently very difficult to treat.” A painkiller with conotoxin called ziconotide has already been approved for human use, but is not available in pill form and requires a spinal cord injection.

Addiction Brain Scans, Unscrambled

We’re used to media splashes about so-called “holes” in the brain. But what neuroimaging really tells us about the effects of drug use is much subtler—and much more helpful.

We’ve come a long way since; the advent and exponential development of neuroimaging techniques allows us to visualize the mind’s hardware—and how it goes awry in addiction—in increasing detail and nuance. But the media bombardment of brightly-colored brain images can be overwhelming—and important points get lost. These slides are meant as a primer on some of the biggest stories to have emerged in addiction neuroimaging, and the insights they give. Of course, these examples are only a thin sliver of the available science—and scientists are still grappling with addiction’s overwhelming complexity. Without dismissing other relevant brain systems or equally important socio-cultural and environmental influences, our focus here is the striatum: a set of structures heavily involved in reward, motivation, habit formation—and the brain’s dopamine system.

One of the earliest addiction imaging experiments was also one of the gutsiest: in 1989 researchers set out to find what cocaine actually did in the brain, where it went, and what that meant. They tagged cocaine with a radioactive element, injected it into healthy volunteers, and used PET (positron emission tomography) to measure the location and time-course of radioactivity emitted. The result? Coke went straight to the striatum: the home of reward signaling and the formation of consequent behaviors. Here we see a horizontal brain slice over time (in minutes). The “hotter” colors represent more cocaine (the striatum is the two sickle-shaped hot-spots near the middle). The study also investigated time-course (right), showing the rapid cocaine uptake needed for a high—this paralleled the subjective effects reported by the volunteers, suggesting the two are related. The work demonstrated in humans that cocaine’s direct effects on the striatum and time-course modulate its subjective effects. The study was later repeated using methamphetamine instead (bottom row): the binding again primarily involved the striatum, but also extended to many other areas. The time-course, again paralleling subjective experience, was much longer-lasting than cocaine—explaining differences between the two stimulants in duration, subjective experience and long-term effects.

Sometimes it’s less obvious why people enjoy a drug. This recent study investigated psilocybin (magic mushrooms), a compound that binds to serotonin receptors and doesn’t have obviously rewarding dopamine effects. MRI (magnetic resonance imaging) was used to measure the magnetic properties of blood flowing into the brain, with the idea that active regions need more blood. Researchers injected volunteers with the drug and placebo, and measured changes in blood flow and oxygenation. To everyone’s surprise, MRI measures decreased with psilocybin, mainly in regions other than the striatum (yellow circle), including areas involved in association, consciousness and “constraining the experience of the world.” The scatterplot shows that the amount of decrease in MRI signal predicted the intensity of subjective effects. The study also found reduced communication between brain regions, suggesting that “decreased activity and connectivity” permits “an unconstrained style of cognition.” So some drugs without a direct striatum/dopamine effect can be found enjoyable, perhaps due more to the reward of changing perceptions—a uniquely human feature that seems hard to model in animals. In a separate study, the group also found that MRI measures related to memory vividness and subjective well-being at follow-up, suggesting a biological basis to the proposed use of psilocybin in psychotherapy.

One of the most consistent “hallmarks” of addiction is that levels of the D2 subtype of dopamine receptors (mostly found in the striatum) are lower in addicted than in non-addicted individuals. These images come from a number of PET studies which assessed D2 receptor levels, by injecting subjects with a radioactive compound that specifically binds to dopamine receptors and comparing levels between groups. The “cooler” colours indicate lower D2 levels in the addicted groups. This represents the possible identification of an addiction “biomarker”—an objective biological measure that can be investigated, monitored and perhaps manipulated for prevention or treatment. The real-world relevance of this is shown in the pink inset: in two studies (cocaine and meth), addicted subjects had their D2 levels measured, went through treatment, and were then contacted again to assess treatment success. Successful responders to treatment were found to have higher D2 levels than those who had relapsed, suggesting that D2 levels have some predictive value for success. Much remains to be filled-in in the dopamine receptor/treatment response black box. But this knowledge can help in the allocation of clinical attention and resources, or the identification of patients who may benefit from one type of treatment—like meds to increase dopamine transmission—over another.

The D2 dopamine receptor has also been used to investigate signs of recovery after abstinence. In this PET image, the “cooler-coloured” striatum of a one-month-abstinent meth user shows lowered binding of the radioactive compound, suggesting fewer receptors. But the striatum grows “bright” again after 14 months’ abstinence, suggesting increase in D2 receptor availability, or recovery of the receptors. This implies that brain cells don’t necessarily disappear permanently, but may temporarily adapt (perhaps retracting receptors in response to the dopamine bombardment from drug use)—or else that the remaining brain cells can compensate. Unfortunately, behavioral tests in the same study didn’t improve as much as D2 measures, and the finding has been difficult to replicate, which limits the study’s implications—but it does show the importance of timing in studies, and suggests that neurochemical changes aren’t necessarily permanent. (By the way, the black spots in the 14-month image are not holes in the brain, but a result of assigning colors to values, and setting the threshold at a certain level).

One problem with neuroimaging is that the pictures often don’t reveal much about functional relevance. How, if at all, do receptor levels translate to differences in experience, behaviour, thinking or feeling? This PET study measured the relationship between dopamine receptors and personality traits. The striatum blobs shown here don’t display radioactivity indicating D2 receptor levels, but rather the strength of the correlation between receptor levels and trait impulsivity (“hotter” colors mean a tighter relationship). In both meth-dependent and healthy subjects, the measures correlated inversely: those with the lowest D2 receptor availability were the most impulsive. This shows that dopamine receptor availability in the striatum can contribute to personality traits for the entire population—and addicted individuals, who tend to be on the low end of the D2 spectrum, are more likely to act impulsively than non-addicted individuals. It’s still frustratingly hard to determine what came first: drug use could cause a decrease in D2, or alternatively, low D2/high impulsivity could make people likelier to use drugs. Still, the study gives the “low D2 addiction biomarker” some behavioral meaning. It also explains some aspects of initiating or continued drug use, and raises clinical implications—as personality traits can be easily assessed and maybe used to evaluate dopamine-related intervention strategies.

Genetic factors contribute significantly to addiction, and imaging techniques can pick up and visualize genotype effects that less sensitive behavioural or self-report measures may not. This study investigated how genetic variation in the dopamine system affects smoking. Dopamine release in a certain part of the striatum is often considered the brain’s reward signal, and can be assessed in humans using PET. This requires measurement of a dopamine receptor-binding radioactive compound at two time-points; the difference between the points shows how much dopamine was released over time, knocking the compound off the receptor. The lower the second PET signal, the more dopamine was released. Subjects were scanned before and after a smoke break, then divided by genotype for three components of the dopamine system—each of which varies in function depending on genotype. Each row on the slide is a component: top, the dopamine transporter; middle, the D4 dopamine receptor; bottom, an enzyme that removes dopamine after release. For all three components, individuals with one genotype (left two panels) released more dopamine during the smoke break than those with another genotype (right two panels). So some people, due to their genetic makeup, find smoking more rewarding than others—and are likelier to continue or escalate use. Tiny biological differences can influence addiction processes, and a better understanding of them can aid prevention and intervention.

Behavioral or process addictions, like compulsive gambling, eating, or sex, have been getting lots of neuroimaging attention, partly due to their surface similarities with drug addiction, but their neurobiology remains largely unexplored. These results from several PET studies measuring D2 dopamine receptors in the striatum show that obese individuals who may be prone to compulsive overeating have low D2 levels—paralleling findings in compulsive drug users. This suggests biological commonalities between behavioural and drug addictions; it’s an exciting area currently gaining research momentum. Interestingly, in compulsive gambling—the only behavioural compulsion currently proposed for re-classification to addiction—low D2 receptor levels haven’t been found, although several studies have searched. This may mean that low D2 levels are sufficient, but not necessary, to drive addiction, and that other factors play a more important role here—or that the low D2 levels seen in drug addicts relate to the effects of drugs themselves, rather than addiction per se. This is a unique chance for scientists to learn about addiction without the potentially interfering effects of drugs, but clinically there are potential problems: drug addiction treatment options may have different effects when aimed at behavioural addictions. Of course, other biological parallels with drug addiction have been identified, and neuroimaging has played an important role in teasing apart the results.

Neuroimaging has enabled many advances in addiction science; it’s also added to the debate on personal culpability in addiction, by highlighting neurobiological factors that aren’t necessarily under our control. But the emotive influence of these images can also be used to more sinister effect, manipulating audiences into knee-jerk reactions. Sometimes this is done for the sake of eyeballs and obviously overwrought (right panel)—but other uses are more serious, including court evidence to support drug-related penalties. Even if an image comes from reputable scientific sources, it’s still subject to interpretation and presentation, which can easily be shifted to fit different needs. So we’re well advised to approach these images with questions. What is actually being shown? What do colors (or their absence) mean? What’s the behavioural significance, if any? And who is being shown? Is this a group of individuals, or one exemplar—and if the latter, is he or she representative of the population, or does the image pit the best in one group against the worst in another? How many times did they use the drug, how heavily, and how long were they abstinent? Could factors other than drug use account for the image? The answers may not be easy to come by. But posing these questions can help overcome gut responses, fostering a fuller, fairer understanding.

In the previous photo, even though the news article claimed to have “conclusively demonstrated severe and multiple disruptions,” the “black holes” don’t indicate dropout of actual brain tissue. They’re a result of threshold-setting: assigning “black vs. colour” at a particular signal value, with the choice of value entirely subjective. This is just one of the many caveats of neuroimaging. In human neuroimaging, for example, actual photographs are rare; more often, images are proxy signals for some biological event that have been digitized and computerized, reconstructed and transformed, and subjected to statistical testing and interpretation. Signals are small, assumptions are many, and at every point, a person intervenes in producing what will ultimately be displayed. The result can sometimes be utter junk—as demonstrated in a study that flashed pictures of human social interactions, and “found” associated brain activation…in a dead fish. Neuroimaging techniques, no matter how brilliant, are removed biological events, so can’t always be assumed to accurately reflect them. Addiction neuroimaging is a tricky area: the field is fraught with political static and agenda. Combine this with the computational limitations of neuroimaging, and emotionally charged headlines can ensue. Ultimately, though, a tool that can visualize the hardware of the mind is extremely valuable in any mental health field. It’s a privilege and a thrill to think of the possibilities ahead.

New Study Examines Psilocybin as Cure for Cocaine Addiction

Hallucinogens show promise in curbing one’s criminal behavior and addictions.

Starting later this year, a researcher at the University of Alabama at Birmingham said he hopes to begin giving psilocybin obtained from hallucinogenic mushrooms to cocaine addicts to study if it can curb addiction.

Peter Hendricks, a clinical psychologist in the School of Public Health has reason to be optimistic.

Hendricks and colleagues studied about 30,000 people charged with a felony who were sent to a diversion program called the Treatment Accountability for Safer Communities (TASC) program, a case management intervention for those with a history of substance use.

Researchers found that those who used hallucinogenic drugs — even when controlled for variables — were less likely to fall back into crime and drug use after the program.

“There was an association between hallucinogen use and outcome in this TASC program, such that hallucinogen use was associated with decreased likelihood of failure,” Hendricks said.

So with this grounding, Hendricks said they are ready to take it to the next step, giving psilocybin pills to cocaine addicts, pending lots of red tape, including approvals from the Food and Drug Administration and the Drug Enforcement Agency. But similar research, with promising results, has been ongoing elsewhere so it is not like they will be plowing new ground for approval, Hendricks said.

Hendricks said the study of hallucinogenics and their medical benefits has enjoyed a resurgence after enduring the negative stigma in the 1960s attached to sensational claims and call for unfettered access made by those such as LSD guru and Harvard University professor Timothy Leary.

“No one that I know is going the route of Timothy Leary who really was unhinged and advocated for everybody to use,” said Hendricks.

It’s still a bit of a mystery how hallucinogens may work to the desired benefits of addiction control, Hendricks said.
It could be they act as a mood elevator. It could be they offer a shot of confidence that the addiction can be beat. Or, it could be something deeper.

Perhaps the hallucinogen, such as the naturally occurring psilocybin mushroom, spurs an introspection that leads to a self-revelation that leads to a big change.

Hendricks calls it an Ebenezer Scrooge moment.

“Something profound happened to Ebenezer Scrooge,” Hendricks said. “Think of Saul on the road to Damascus, a great persecutor of Christians, has some sort of experience and transforms over night.”

It’s not that Hendricks is implying Paul/Saul was eating magic mushrooms. He brings these examples up as analogies to the kind of transformative spiritual experience hallucinogens might help provoke in changing an addict’s behavior.

Brain Restoration for Addiction & Disease: Too Good to be True?

Could mega doses of energy-giving NAD—which allegedly relieves withdrawal symptoms, flushes out stored drugs in the body and replenishes balance in the brain—really be the cure-all for addiction as well as many other diseases and mental health disorders?

When Paul decided again it was time to do something about his drug addiction, he knew the usual routes wouldn’t work. While using a variety of substances for at least two-thirds of his life – injecting heroin in the last 20 years of it – he also became a veteran of just about every traditional rehab/detox program in the book. Twelve to be exact; with no permanent results or positive outcomes to speak of.

Hearing the remarkable claims from a Brain Restoration Therapy outpatient clinic immediately sent him into skeptic mode: This is too good to be true. How can I kick drugs with just an infusion of some concoction? What about withdrawal? Side effects? And, if it really works, will it last? Sounded far too simple for this jaded, somewhat cynical, pushing-60 drug addict.

Figuring he had nothing to lose, he called and arranged a free consultation. After listening to details of their success rate and impressed with assertions of little or no withdrawal symptoms, he signed up for the treatment – albeit with some reluctance. His wife’s divorce threat had something to do with enrolling, but it was more about life hitting bottom one more time.

Groggily arriving at the crack of 9 am the next day, a warmly friendly nurse in navy blue scrubs hooked him up to an IV. Told that all he needed to do was relax, he settled into the oversize leather lounge chair. If nothing else he’d be able to listen to music, watch a few videos, and read a bit, he thought. Observing the slow drip of clear liquid entering his veins, he listlessly wondered what he would do next if this latest treatment failed.

At the end of the first eight-hour treatment, Paul says he already felt different. He couldn’t quite explain it, he recalls, but his mind was clearer. He felt energized. More alive. And definitely more present.

Returning daily for nine more treatments, he noticed a growing list of undeniable and rather dramatic changes. His outlook was more positive and he was optimistically able to imagine a future for himself, one he’d stopped envisioning years ago. His mind was as sharp as it had been prior to years of drug use.

The best part, he says, true to the claims, there were few or no withdrawal symptoms therefore no need for a replacement drug to get him through yet another grueling detox. He also realized he had no cravings, the primary cause of his continued bouts of relapse. His disbelief completely gone, he recalls, he concluded he was drug free.

But would it last?

Ann Rodgers, the Director of Brain Restoration Therapy, meets me at the door of the Center for Health and Wellbeing in San Diego, CA., where the clinic operates under medical supervision. It’s difficult to not get caught up in her animated explanation of the benefits of this program. “The treatment utilizes a mega dose of NAD [Nicotinamide Adenine Dinucleotide is a co-enzyme of niacin that is the key fuel for energy production in every cell of the body] in an IV form, and it’s clinically proven with a 90% no-craving statistic,” she excitedly offers.

Listening quietly as she rapidly fires glowing statistics in my direction, my skeptical mind revs into full gear. “With literally no reported side-effects,” she says, “the protocol reduces withdrawal symptoms by 70-80% without using replacement drugs, and restores the patient’s clarity and well-being to pre-use levels. Six to ten days of treatment is like a seven or eight month jump-start to recovery.” All this expounded with the tone of a bragging parent.

Rodgers tells me that although relatively new to America, NAD treatment has been successfully used in South Africa since 1961, with centers there reporting more than 22,000 people treated. [Rodgers could not provide any research report from South Africa to confirm this, only a report from individual clinicians who treated patients with NAD. Separately, I could not confirm the 22,000 figure.]

The first NAD clinic to open in the States was in Springfield, Louisiana, founded by psychotherapist Paula Mestayer, M.Ed, LPC, FAPA, along with her psychiatrist husband Richard. The couple discovered the treatment when their 16-year-old adopted daughter became addicted to alcohol and found her way into NAD treatment. Thrilled to see her positive results, they conducted their own research and in 2001, putting aside their cumulative years of treating addicts with therapy, they opened the Springfield Wellness Center on a private 500-acre estate. They claim to have treated more than 1,000 patients since then with NAD.

Springfield Wellness Center’s ten day addiction detox, Mestayer asserts when I contact her, has been used successfully on people hooked on prescription drugs, alcohol, opiates, benzos, stimulants, cocaine, marijuana, suboxone, and methadone.

Mestayer noted in our interview that “like a thumb print, all brains are unique, so this protocol is more like an art than a science.” Each patient, she pointed out, responds differently to NAD, with one factor being their type of addiction. She therefore adjusts the dosage and prescribes booster NAD treatments when necessary, especially when a patient feels vulnerable or if any cravings return. “I always emphasize that there may be a period of time where they need maintenance, either by an occasional booster or other means of support. Some patients have gone nine years without needing a booster, but many do.” Mestayer generally prescribes oral NAD as a supplement to the IVs, on the grounds that the more NAD that builds up in an addict’s system, the less prone he or she is to succumbing to cravings

Mestayer emphasizes that the treatment is “not a cure, but rather maintenance,” and notes that it remains a mystery as to why NAD works more successfully on some addictions than others. “The highest success rate is on alcohol and opiate users,” she says. “The only failures are people who were using during the treatment or not committed to their maintenance.” Even so, she like Rodgers encourages all patients to seek therapy and support groups to address underlying psychological issues.

In California, I asked Rodgers if the treatment is just a substitute “high.” Rodgers countered with “it’s a state of well-being that allows the client to feel content with their life, so many don’t even consider going back to being an addict, no desire for that miserable life anymore. It’s as if they become themselves again, back to their natural state, seeing themselves as a different person, separate from being an addicted person. It’s not just a detox; it’s a total state of sobriety.”

With only a handful of other U.S. clinics in existence, the technology has yet to become familiar to most of the recovery community. Even so, Ann Rodgers says she is certain that once knowledge of NAD spreads, it will be seen as a revolution in addiction treatment. “[Members of] the AA community have been resistant to it at first, but once they read the evidence and witness the results, they embrace it,” she claims.

Her San Diego clinic is modern, serenely comfortable and well-appointed. Located on the first floor of the larger health center, it’s been open for over three years and has treated nearly 40 patients. Rodgers recently opened another facility in Los Angeles, CA, at the Center for Optimum Health.

HOW THE TREATMENT WORKS

Dr. Janette Gray, a California licensed internist and a pioneer in combining allopathic and holistic medical approaches, is the center’s medical director. Board certified in Holistic Integrative Medicine, she worked for years in the prison system helping inmates get off drugs and has extensive experience with the agonies of drug withdrawal. “Seizures, nausea and vomiting, intense sweating and physical pain are standard, but that is greatly minimized with this program,” she tells me. “The most common withdrawal symptom is feeling a little bit flu-ish…[which] passes quickly.”

Gray rattles off to me a scientific explanation behind the BR treatment. The protocol, she says, employs a proprietary NAD formula administered by IV. NAD is an element that reacts with oxygen in the cell’s mitochondria in order to create energy for movement, breathing, heartbeat, blood pumping, digesting food, brain functions, and generally living life. It is available in low doses over the counter.

Studies have found that those with extremely low NAD levels (which can be present even at birth) are far more vulnerable to addiction as well as other diseases and to chronic physical conditions. There is a preponderance of low levels of NAD present in Western society as it is mostly lost in cooking and food processing. What little remains is broken down by stomach acid, degraded before it’s absorbed from the digestive tract.

When the clinic’s all-natural NAD is received directly through an IV, the nutrients bypass the stomach and go directly to the receptors in the brain, Gray tells me. According to Gray, this immediately produces palpable positive results as the nutrients bathe the brain in a continuous pool of natural and highly therapeutic co-enzymes.

Since NAD is a detoxifier, it takes days (rather than weeks or months), to flush out stored drugs from the body and its organs, replenish balance in the brain, and reverse damage. Results can be mental clarity, cognitive function increase, focus and concentration returns, more energy, better mood, positive outlook. And this happens cold turkey.

“We find that one of the big reasons this treatment works is because it’s so rapid,” Gray says. The majority of drug addicted individuals, she claims, need about ten days of infusions, sometimes less. “It keeps people inspired when they see fast results,” she adds, “especially when they feel better than they did before, or perhaps ever in their life.”

Based on each individual, Gray like Mestayer sometimes recommends a periodic “booster” which can be one or two days of IV to support the results achieved in the initial treatment. She also prescribes a co-enzyme that, she says, helps maintain higher levels of NAD in the body. If a client relapses, she claims, one or two treatments can quickly get them sober and craving-free again.

The clinic also offers a four day “Tune Up” treatment for those suffering from stress, anxiety, irritability, low energy, PTSD and depression. The clinics also address other non-substance related addictions such as gambling.

NAD was first discovered in 1936, but World War II stopped the research. It was patented for treatment of drug addiction and schizophrenia in 1961 based on an 11,000 patient study. Sloughed aside with the discovery of methadone – a far more lucrative choice at the time for drug companies – NAD went “underground.”

Research has shown that NAD increases the synthesis of certain neurotransmitters in the brain known to be effective in correcting specific chemical imbalances. Some of these chemical imbalances underpin addiction, mental illness, anxiety, aggression, depression, despair and hopelessness. Fatigue is often the first signal of NAD deprivation; other clues may include depression and anxiety in children. Almost any chronic disease, including Parkinson’s, can also be indicative of deficiency.

There is some research and other reports indicating that NAD might be effective treatment for a host of other ailments including schizophrenia, PTSD, chronic fatigue, weak immune system, memory disturbance, sleep problems, concentration defects, blood pressure, poor cholesterol levels, sugar metabolism and diabetes, muscle pain and weakness, joint pain and stiffness, headaches, fevers, sore throats and swollen lymph glands. Clinical research has shown it is a potent biological antioxidant which can aid in preventing cell damage and a variety of diseases, cancer included.

There is also some evidence that NAD therapy can help with aging. Dr. David Sinclair, professor of genetics at Harvard Medical School, in a paper published in the journal Cell, describes a compound naturally made by young cells that is able to revive older cells, allowing them to be energetic and youthful again. With adequate amounts of NAD, aging can theoretically be reversed, he asserts. “When we give the molecule, the cells think oxygen levels are normal and everything revs back up again,” Sinclair wrote.

Pondering these claims raises the un-researched theory of whether NAD deficiency might be an unrecognized epidemic disease of our time.

THE BIOCHEMICAL PATH TO PERSONAL DEFICIENCY

Before I interviewed patients of the two clinics to determine whether they validated the positive assertions of Rodgers, Gray and Mestayer (they do, as you will read below), I decided to research more carefully the biology of the NAD process to determine whether there is a basis in science for their claims even in the absence of double-blind long-term studies. What I learned is relevant to the health, mental vitality and even possibly, as Sinclair asserts, to the aging of each of us, not only to addicts.

I learned that a range of vitamins, minerals, carbohydrates, proteins and fats from our diet provide the building blocks to create what medicine refers to as the “Citric Acid Cycle,” which names the energy it takes to produce NAD and link it with hydrogen (NADH). NADH enters the electron transport chain in the mitochondria and is sparked with oxygen – and the outcome is energy. This in turn fuels the 86,000 daily beats of the heart, enabling muscles to contract, and provides the cellular energy requirements of the 100 trillion cells of the body. The brain consumes about one-third of all the energy produced, so if the NADH is low, brain functions suffer. If any of the nutritional factors that produce NAD are low, energy production is weakened.

Often NAD deficiency is first evident in brain-related symptoms of poor concentration, difficulty focusing, and attention deficit disorders. If the energy shortage lasts long enough, brain neurons cannot synthesize neurotransmitters. When this occurs, the molecules of consciousness (such as serotonin, dopamine, and noradrenaline) are affected. Anxiety, depression, sleep disturbance and other mood changes can then arise.

Also important to know is that the crucial enzymes that catalyze the Citric Acid Cycle are inhibited or destroyed by chemical toxins that create oxidative, or free radical damage. Sources of the damage include cigarette smoke, drugs, chronic stress, sedentary living, as well as the accumulation of the myriad toxins found in daily life such as in pesticides.

Along with acquired NAD deficiency, there may also be a genetic disorder that is present at birth. Symptoms can appear in young children as difficulty sleeping, behavioral problems, hyperactivity, impaired concentration, academic stress and underachievement.

Moreover, NAD deficiency that induces fatigue and depression increases a propensity to use drugs and alcohol in order to improve energy and mood – simply to feel better. The self-medicating cycle is a common story reported by many addicts, and leads to even lower NAD. A vicious cycle ensues.

There is some history to using megavitamins as potential cures for addiction, including dating back to Bill Wilson’s (aka “Bill W.” the revered co-founder of Alcoholics Anonymous) ideas and experience. In 1960 Wilson underwent a major shift in his beliefs about the value of nutrition in achieving sobriety when he met Dr. Humphry Osmond who introduced him to the concept of megavitamin therapy. Curious, Wilson became a guinea pig, taking 3,000 mg of niacin daily. Within a few weeks, fatigue and depression (symptoms of low NAD) which had plagued him for years, were gone.

Seeking to share this exciting discovery, Wilson gave the same doses to 30 of his close friends in AA, hoping it could be replicated. Of the 30, 20 he later reported became free of anxiety, tension and depression in one or two months. This dramatically reduced their alcohol consumption.

Wilson wrote a detailed report called “The Vitamin B 3 Therapy” and distributed thousands of copies as a pamphlet. Because the information was controversial, way ahead of its time and ran counter to the precepts of the 12-Step Program, Wilson became unpopular with the board of directors of AA International and the information was squelched

THE PATIENTS HAVE THEIR SAY

Unfortunately, newer in-depth scientific studies in the U.S. on the long-term benefit of NAD treatment on addiction and alcoholism have never been financed. That leaves largely the claims of clinic operators and their patients to bear out the assumption that, by virtue of its catalytic role in the body, NAD might in fact be an effective agent in addiction and alcohol treatment.

Rodger’s California centers are too new to have meaningful data on the long-term effects of NAD treatment based on follow-up interviews with patients, though Rodgers says she intends to set up a formal study of her patients in the near future. Mestayer’s Louisiana clinic did collect data for some years which was lost when their clinic was hit hard during hurricane Katrina. She has been collecting more recent statistics on the long-term effects of the NAD formula her clinic uses which, she claims, show an even higher success rate than the earlier formula.

In fact, the statistics if true are astounding, with some earlier participants in the Louisiana clinic achieving, according to Mestayer, nine years of sobriety.

“Statistically,” Rodgers claims, “70% of patients are craving-free by day five; 90% by day ten.” She adds that some reported having no physical memory of how drugs even felt, clearing their desire for them.

As testimonials, Rodgers provided me several video-taped former patients, each boasting tremendous success. One was from a man who claimed he had been taking 30 Oxycontins a day for 12 years. Another was from a woman who had been suicidal, shot speed for 20 years. Another woman reported a personal trauma that threw her into deep depression. Each claimed to have maintained a drug free life since their treatment.

I inquire about Paul who went through treatment three years ago: Is he still clean and sober?

“Not only is he clean and sober, he paid for two of his friends to do the treatment,” Rodgers tells me, with tears in her eyes. “He no longer defines himself as an addict since his thought patterns have shifted and he sees life so differently.”

Separately, I interviewed four people who have gone through treatment at either the San Diego or Springfield, Louisiana centers. Their stories:

• Doug, a health-conscious personal fitness trainer who experienced CTS (Chronic Traumatic Encylopathy) from several football injuries, would drink copious amounts of vodka at night to allow his amped-up body and mind to relax and shut down. He tried exercise and nutrition to get past anxiety-based insomnia; nothing worked. He knew that a 12-step program or therapy that dealt with past history wouldn’t work for him given that his issue was clearly a chemical imbalance. After just 20 minutes with his first NAD IV, he experienced a state of well-being he hadn’t felt in his entire adult life. His angst was gone, and the neuro-transmitters that lay dormant in his brain felt alive again. After the first day of treatment he was able to sleep soundly, and he told me he’d been craving-free for more than four months. He takes an NAD supplement and goes back monthly for a booster.

• After several tours of duty in Iraq, Patrick, a Marine, became a heavy heroin user after trying many other ways to self-medicate his PTSD and resulting insomnia. He admitted himself to two traditional inpatient treatments, one lasting 57 days. The first day out of each, he relapsed. After day four of the NAD treatment, during which he experienced no withdrawal symptoms, he felt completely clear and now sleeps without nightmares. He gets boosters once a month and has been drug free for several years.

• Steve, also an Iraq veteran, had nine neck surgeries in five years. He used pain pills and opiate drugs to deal with constant physical pain as well as intense PTSD. He entered the NAD program out of a desperate desire to be free of his addictions in that he has children and perceived a good life ahead of him. Starting the NAD program with a pain scale of eight, within ten days the pain eased down to a one. On bad days, he says, it now goes up to a two, but is easily managed with a couple of Aleve. With only slight withdrawal symptoms, he told me he is now 100% craving free and his PTSD is also gone. He continues to take the oral NAD supplement but has not needed any booster treatments. He did the program in November, 2013.

• Sandy is a young woman whose addiction to pain killers and amphetamines spiraled from recreational use to a full-on necessity. For three years she was not able to get out of bed without drugs, the lowest point of her life. She researched various other programs and told me she was baffled by the concept of replacing one drug addiction with another as a “cure.” After eight days of NAD treatment, she no longer thinks about using at all. Her mood is good, her energy is up, and she’s happy, she reported. Clean for a year and a half, she believes it was the combination of the in-home IV treatment she received and the warm caring from the clinic staff that made the difference. She has had two boosters and believes she won’t need any more to remain addiction free.

I ask Ann Rodgers if the treatment works for everyone and if not, is there a typical profile of who it doesn’t work for? “No, it doesn’t work 100% of the time,” she replies. “Interestingly, sometimes it doesn’t work for young heroin addicts. It could be because they aren’t emotionally mature enough to deal with their issues, or perhaps they don’t have a good support system in place yet.”

One young man, Rodgers notes, went through the program a year ago and did extremely well until he entered an intimate relationship. “That triggered emotional issues,” Rodgers says, and he returned to the arms of heroin. The Center then refused to treat him again as he refused to enter rehab, an essential aftercare resource in which BR+ patients are encouraged to participate.

“Patients often feel like a fish-out-of-water when out of the drug culture they are accustomed to, and they need to find a structure to help them live drug free,” Rodgers explained. Accordingly, patients are informed of the importance of addressing any long-standing psychological issues and of re-learning how to live life as a non-addicted person, and they are encouraged to enter after-care programs that provide such support. “Rehab programs work so much better after doing NAD therapy since the person is so clear, more willing to make it work in their lives,” Rodgers says. “Their confidence allows them to make significant shifts in other areas of life so they are far less likely to relapse when they re-enter society.

“We really see ourselves reversing the customary order of mind/body to body/mind… by addressing the bio-chemical issues first it makes it so much easier to shift other areas of an addict’s life.”

Although the clinic runs its own therapeutic center, the staff advocates follow-up support groups that can include 12-step programs and/or conjunctive therapies such as outside psychological and spiritual counseling. As part of one of the largest integrative medicine centers in California, the Center for Health and Wellbeing, the clinic itself offers intensive psychotherapy along with a recovery coach. Patient options include an IOP, sober living, or simply going home. The center also offers a full menu of complementary programs including massage therapy, cranial sacral therapy, naturopathic, nutritional counseling, acupuncture, marriage and family therapy and chiropractic, all of which Dr. Gray prescribes on an individual basis.

Separate from after-care, could NAD itself turn out to be something of a miracle cure or at least pre-cure for addicts? As more people go through the programs, there will be more statistics on permanency of results but no fully authenticated research until some serious independent and double-blind studies are undertaken by scientists, medical professionals or companies who can attract the funds to finance research. Meanwhile, NAD figures to remain something of a blip on the treatment scene attracting people like Paul who said simply: “There is just nothing to lose.”

Man brews beer inside his stomach

Brewing beer at home has long been a pastime of the beverage’s top aficionados, but a substance unavailable for consumption was brewing inside the gut of a 61-year-old Texas man, and it was enough to make him drunk, without ever taking a sip.

A Panola College case study details the man who for five years would become inexplicably intoxicated without having a single drop of alcohol, resulting from a rare condition called auto-brewery syndrome.

“He would get drunk out of the blue – on a Sunday morning after being at church, or really, just anytime,” Barbara Cordell, co-author of the study, told NPR. “His wife was so dismayed about it that she even bought a Breathalyzer.”

According to the report, the man’s Breathalyzer results would often raise as high as .33 to .40, roughly three times the legal limit of .08. A November 2009 incident landed him in the emergency room – on a day where he had not consumed any alcohol – where perplexed doctors found his blood alcohol concentration to be 0.37 and labeled him as a “closet drinker.”

Auto-brewery syndrome literally mimics the functionality of a home brewery inside the body. An overabundance of yeast in the stomach ferments ingested carbohydrates into ethanol. Researchers found that the patient had an infection with Saccharomyces cerevisiae – commonly known as brewer’s yeast – which would act up when he would eat starchy foods such as bread or sugary drinks. The syndrome is rare and has only been observed a few times in the last three decades. It also does not discriminate against age. Researchers in 2001 observed a 13 year old girl who exhibited similar conditions after consuming fruity drinks. The earliest reported cases of the syndrome were found in Japan in the early 1970’s. Most cases were the result of antibiotic prescriptions, which can kill bacteria in the gut leaving room for yeast to grow. The Texas man had been on antibiotic treatment after a 2004 foot surgery.

The unidentified man survived the 2009 incident, and now adheres to a strict diet.