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Vigabatrin – Not Useful For Treatment Of Cocaine Dependence:

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By Will Boggs, MD

NEW YORK (Reuters Health) Apr 16 – The GABA-transaminase inhibitor vigabatrin failed to help patients with cocaine dependence in a randomized multisite study.

“Based on our clinical trial it seems unlikely that vigabatrin will ever be found to be effective in the treatment of cocaine dependence,” Dr. Eugene C. Somoza from the Cincinnati Veterans Affairs Medical Center and the University of Cincinnati in Ohio told Reuters Health.

Dr. Somoza and colleagues compared vigabatrin with placebo in a 12-week clinical trial with 186 participants at 11 U.S. sites. Everyone received weekly computerized cognitive behavioral therapy plus biweekly half-hour individual sessions with a counselor. One hundred forty-one patients completed the study, according to a report April 10th online in JAMA Psychiatry.

Cocaine abstinence was defined by two measures: self-report of cocaine use, and quantitative measurements of the cocaine metabolite benzoylecgonine and creatinine.

Overall, about 25% of urine samples were missing. Roughly 11% of samples in each group went missing during active treatment. Another 14% in each group were missing due to study dropout. And in both groups, only 55% of participants were more than 90% compliant, and only 66% were more than 70% compliant. In 39 patients the primary outcome could not be determined because of insufficient study participation.

With these shortcomings in mind, only seven of 92 vigabatrin participants met the primary endpoint of abstinence during the last two weeks of the 12-week treatment phase, compared with five of 94 placebo participants (7.6% vs 5.3%; p=0.67).

There were no significant differences between the groups in weekly fraction of cocaine use days, percentage of drug-free urine samples during weeks one through 13, or improvements in craving or global function.

“In a post hoc measure of vigabatrin in the urines of some participants it was estimated that the actual adherence may have been around 50%,” Dr. Somoza said. “Nevertheless, an analysis of just the adherent patients revealed that the medication was still not efficacious.”

Adverse event rates were similar in the two groups, except that placebo participants reported significantly more headaches.

Changes in visual acuity have been reported in association with vigabatrin use, but there were no clinically significant decreases in visual acuity during the study.

These results contrast with findings in a Mexican placebo-controlled trial in which 28% (n=14) of vigabatrin participants maintained full abstinence during the last three weeks of treatment, compared with 7.5% (n=4) of placebo participants (p=0.009).

The researchers suggest that their disappointing results may have been due to “weak efficacy of the drug” or significant nonadherence.

They also note that a third vigabatrin trial, funded by the National Institute on Drug Abuse, was designed “to more adequately address medication adherence (e.g., with once-daily dosage, observed dosing three times per week, and riboflavin level monitoring to measure compliance).”

Dr. Somoza said, “I know that this trial ended several months ago, but I do not know when the official results will be announced.” He said the results might be presented at the annual College on Problems of Drug Dependence (CPDD) meeting in San Diego in June.

“Cocaine is very different from other addictive agents, particularly because it lacks the intense withdrawal symptoms of other substances like opioids, alcohol, and benzodiazepines,” Dr. Somoza explained. “Thus, the cocaine withdrawal symptoms are so mild, non-specific, and often non-existent that they cannot be used to detect cocaine withdrawal. Note that in spite of this, DSM5 continues to assign as much importance to cocaine withdrawal symptoms as to the other addictive agents.”

“My feeling is that the scientific community and NIDA need to put a stronger emphasis on finding a better outcome variable for use in cocaine clinical trials to replace what is currently being used,” Dr. Somoza continued. “At the present time most clinical trials on cocaine employ only self-report measures of cocaine use. They generally claim that these self-reports are ‘validated’ by measuring benzoylecgonine (BE) levels in urine. However these BE measures are generally done qualitatively (and infrequently). Also, the ‘validation’ procedures tend to be quite feeble and seldom described, thereby making self-reports the de facto primary outcome variable.”

 

JAMA Psychiatry 2013.

Exercise May Mitigate Brain Damage Due to Heavy Drinking

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Exercise May Mitigate Brain Damage Due to Heavy Drinking

Deborah Brauser (From Medscape)

Apr 16, 2013

Aerobic exercise may help prevent some of the brain damage caused by the effects of heavy alcohol consumption, preliminary research suggests.

A study of adults who drank heavily showed that those who participated in low levels of aerobic exercise had decreases in white matter integrity in the brain’s external capsule and superior longitudinal fasciculus (SLF) — areas that are important for cognitive, behavioral, and emotional functioning.

However, the association between alcohol intake and white matter health was not significant for those who reported high levels of exercise involvement.

“The results suggest a first step in better understanding the relationship between the brain, exercise, and alcohol consumption,” Hollis C. Karoly, from the Department of Psychology and Neuroscience at the University of Colorado at Boulder, told Medscape Medical News.

She noted in a release that although it is common knowledge that long-term alcohol exposure is linked to white matter damage, “little is known about how this damage could be reversed or prevented.”

On the basis of their findings, “aerobic exercise appears to be a promising candidate for decreasing alcohol-related brain damage,” said Karoly, adding that clinicians should consider prescribing this type of exercise as adjunct treatment for patients with a history of heavy alcohol use.

“We already know how good exercise is for your heart, your muscles, and your lungs. So the suggestion that it could also lead to positive changes in brain health is not all that surprising. It’s something that’s important for overall health.”

The study was published online April 2 in Alcoholism: Clinical and Experimental Research.

Protective Effect

According to the investigators, aerobic exercise has been shown to decrease cognitive decline and negative neural changes associated with aging and with several neurologic disorders.

“Engaging in regular aerobic exercise has been found to improve learning, memory, and self-control,” said Karoly, adding that this appears to be particularly true among older adults who exercise regularly.

She noted that exercise has also been shown to protect white matter from age-associated damage.

“White matter is a crucial part of the nervous system, relaying information between areas of the brain. In general, white matter damage can lead to motor deficits, sensory problems, and cognitive difficulties.”

In addition, heavy use of alcohol “is associated with a number of deleterious health outcomes, such as…widespread damage to the brain, including gray and white matter loss,” write the researchers.

Given all of this, “it seemed likely that aerobic exercise may work to reverse or prevent some of the damage to the brain caused by chronic alcohol consumption,” said Karoly.

Investigators assessed data on 60 adults between the ages of 21 and 55 years who participated in 1 of several previous studies on alcohol and nicotine use.

All had undergone a diffusion tensor imaging scan and had completed the Voluntary Aerobic Exercise Questionnaire; the Alcohol Use Disorders Identification Test (AUDIT); the Time Line Follow Back (TLFB), in which participants recorded the number of drinks consumed in the last 60 days; and the Impaired Control Scale, which is a measure of loss of control over drinking.

Relationships between these factors were assessed by measuring fractional anisotropy in the brain’s SLF, external capsule, fornix, and superior and anterior corona radiata.

“These five…tracts were selected based upon their demonstrated association with alcohol consumption in several previous studies,” report the investigators.

Results showed a significant association between level of aerobic exercise participation and alcohol consumption on fractional anisotropy in both the external capsule and the SLF (both areas, P < .05).

There was a strong link between low exercise and decreased white matter integrity in both of these brain areas, and this association did not change significantly after adjusting for use of cigarettes or cannabis.

“Both the external capsule and [SLF] connect important brain areas, so damage to these tracts may have a host of more specific implications for negatively impacting cognitive, behavioral, and emotional functioning,” said Karoly.

No Causal Claims Yet

No relationship was found between alcohol intake and white matter health for the average or above-average exercisers.

In addition, for the low exercisers, there was a stronger association between alcohol intake and loss of control over drinking than for the high exercisers (P < .01). However, this association was only found in the AUDIT measure and not in the TLFB.

Karoly pointed out that the study did not prove a causal effect or even that aerobic exercise is protective against alcohol-related white matter damage, although the results “are consistent with the notion that exercise may be protective.”

“This was more of an associational study, so making a definitive claim like that is a little too strong right now. We don’t know the mechanisms by which this effect is happening, and we didn’t look at this over time to see if it could repair damage that has already happened,” she said.

In addition, future studies “relating neural characteristics to exercise behavior” should consider lifelong exercise patterns as well as more recent participation, note the investigators. They add that a healthier diet and improved sleep that often comes with a heavy exercise lifestyle should also be examined.

Karoly added that the researchers are now planning a new study that will also assess “dose levels” of aerobic exercise (including type, duration, intensity, and frequency) on white matter effects.

Compelling Study

Susan F. Tapert, PhD, professor of psychiatry at the University of California, San Diego, and chief of psychology at the VA San Diego Healthcare System Psychology Service, said in a release that the focus of this study is highly significant because, although heavy drinking has been linked to white matter damage, “it is unclear why the effects are more prominent in some individuals than in others.”

“Although we don’t know yet if the exercise is protecting against alcohol-related damage, or if it is a sign of factors linked to brain health, this is a very compelling study,” said Dr. Tapert, who was not involved with this research.

“This suggests that individuals who have experienced alcohol-related brain problems could possibly use exercise to help recover those effects; studying people over time will tell us if this is in fact the case.”

She added that she hoped the findings “drive more research” into this topic area.

“From a neurobiological perspective, it will be very interesting to see how aerobic exercise could potentially mitigate inflammatory, oxidative, and other sources of neural injury produced by heavy alcohol use,” concluded Dr. Tapert.

The study was funded by grants from the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The study authors have reported no relevant financial relationships.

Alcohol Clin Exp Res. Published online April 2, 2013.

Penn. State – #1 Party School in the Nation! — By Joe Schrank

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On Tuesday afternoons at the center for counseling services on the campus of Penn. State, there is a substance abuse group. There are other groups offered at the center as well. Groups for: undergrads, women, depression management, mindfulness (what?), stress management and yes, a substance abuse group on Tuesday afternoons. Just how out of control is undergraduate drinking on American campuses and just what are we doing about it?

According to the Princeton review, Penn. State is the #1 party school in the nation based on their criteria and responses from an online survey.  Graham Spainer, president of the university says he doesn’t mind being known as a party school but wishes they weren’t number 1.  This is odd considering Penn State routinely lists alcohol as one of the biggest problems they have in Happy Valley.

A recent broadcast of “This American Life” from the Penn State Campus observed all kinds of drunken mayhem right outside the door of one of the producers of the show. In the span of 30 minutes the show producer witnessed drunken students stealing a stop sign as well as three girls who hike up their skirts and pee in her yard. We have always expected boys to pee in the yard but it’s good to know that this practice has now crossed gender lines. Later the show interviewed a girl celebrating her 21st birthday at a football tailgate party. Stating her goal was to get drunk. The celebrants included her parents and women from a neighboring tailgate who came over to watch this young girl get drunk and deliver her some kind of lemonade and vodka concoction.

According to student surveys, 75% of the Penn State undergrad population (more than 30,000 young men and women) drinks an average of 4.5 drinks on both Friday and Saturday nights more than enough for what the Harvard School of Public Health calls “binge drinking”. This does not include what they are doing on other nights. What is the problem with this? Is this wholesome behavior?  A rite of passage? Is it the entitlement of a generation raised on being told they were all “geniuses” and protected from human experience for fear they would have ‘low self esteem”?  I don’t think that is it because back in my day, we behaved in largely the same way. Inconsiderate, entitled to drink, party and do as we pleased because we were ‘in college”. Is this behavior so enmeshed into the American experience that we just accept it? Does it need to be “corrected”?

Strangely, for a guy whose life is so steeped in living free of intoxicants, I kind of think much of what goes on is late adolescent hijinks, that when sequestered to certain areas is harmless fun. Incidentally it seems that one of the biggest issues at Penn. State is the conflict that the undergrad revelry creates for the families that live on or near fraternity row. Umm, how about move dip shit? Maybe it is kids just being kids. I can’t imagine having 40,000 young people living in close proximity of each other without many things going on. In one sense, Penn State seems pretty honest about it. They don’t seem to be telling the kids not to drink in a hypocritical scolding. Many of the young people who live this way will be OK. It is true that kids will be kids and for most, they will age out of this kind of lifestyle.

What is disheartening about the substance abuse climate at Penn State, and college life in general, is the flagrant disregard for the recovery life and culture.  Considering the overwhelming amount of drinking on the campus, how would a kid in recovery make it? The simple answer is, they wouldn’t. How would a kid questioning what impact partying is having on their life flush that out at Penn State? I guess they could attend the group on Tuesdays but is that really adequate? The short answer is No, it is not in any way enough to support a young person who is having issues with alcohol. My issue is not that Penn State has a culture of drinking but that they don’t have a culture of recovery and marginalizes youth who want to live a recovery lifestyle. Nobody can foster a recovery lifestyle alone. We all need peer support, community, a sense of belonging, and a blend of community based and professional helping to sustain recovery. So I guess, kids who want this are not eligible to attend Penn State? That seems wrong, is it different from excluding a kid in a wheel chair? How about a kid with diabetes? What if they were raised in Pennsylvania, grew up watching Nittany Lion football, idolizing Joe Paterno is it fair to deliver the message that a huge land grant university can’t accommodate you? Fair or not, that is the message. On the off-chance that someone undergoing treatment at Hazelden youth and family or at Caron’s young adult program is reading this and thinking about how to integrate into an undergraduate life, scratch Penn. State off the list.

Recovery is never served by an evangelical membership drive. It makes no sense to try to police an entire culture on undergraduate campuses. Not to mention that I don’t think everyone who drinks has a problem. I loved every beer I drank out of a red cup and oh how I wish I still could but I don’t think everyone else should be sober, it’s really not my business. What does make sense is to start to think of recovery as something for young people and to make strides toward treating it as the acute illness that it is. What’s the worst thing that could happen? Kids might stay sober?

Recovery Ride Spin Class Play List 4-15-2013

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Great Ride Today!!!

1) New England                                               Jonathan Richman

2) No Rain                                                       Blind Melon

3) All right Now                                                 Free

4) You get what you give                                  New Radicals

5) Tumbling Dice                                              The Rolling Stone

6)  Bullet With Butterfly Wings                           Smashing Pumpkins

7) Elderly Woman Behind the Counter                Pearl Jam

8) Judy is a Punk                                             The Ramones

9) This is radio clash                                         The Clash

10) Basket Case                                               Green Day

11) Ball and Chain                                            Social Distortion

12) Misty Mountain Hop                                    Led Zeppelin

13) Don’t look back in anger                             Oasis

14) High Fidelity                                               Elvis Costello

15)   My ever Changing Moods                          The Style Council

Non GMO Stickers at Whole Foods – Chef Rob Endelman

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“NON GMO Project Verified” Stickers Appear at Whole Foods

Whole Foods, just a couple weeks after announcing that it will label foods containing genetically-engineered ingredients by 2018, has already started placing “NON GMO Project Verified” stickers in front of qualifying foods.

The accompanying photo is of the vegetable oil section, which, in standard supermarkets, is a hotbed for genetic engineering since about 90 percent of American canola, corn and soybeans (the staples of commercial vegetable oils) are from genetically-engineered plants.

Is it any wonder why the big food and chemical companies spend tens of millions of dollars to defeat state and labeling initiatives? But, we should all hope, the tide is turning against these denizens of disaster.