Medicine proves a promising treatment in the battle against alcohol dependence

October 09, 2007

Researchers at the University of Virginia have led a multisite clinical trial showing that the drug topiramate is significantly more efficacious than placebo at curbing alcohol dependence. Subjects had to be drinking heavily and were not abstinent when they started the trial.

"Topiramate has emerged as a promising treatment for people with alcohol dependence," says the lead author, Professor Bankole Johnson, D.Sc., M.D., Ph.D., M.Phil., FRCPsych., who is chairman of the UVa Department of Psychiatry and Neurobehavioral Sciences. "Our finding in this national study was that topiramate is a safe and highly efficacious medicine that can be paired with a 15-minute brief intervention by health practitioners who are not addiction specialists. Community practice settings in the United States and in many parts of the world, therefore, have the potential to use this combination treatment."

Greater access to treatment with an effective medicine that can be delivered with a brief intervention by non-specialists should lead to success for many people battling the alcoholism disease, Prof. Johnson noted. "One of our next steps is to directly study topiramate's efficacy in treating alcoholics within community practice settings."

During the 14-week study published in the October 10 issue of the Journal of the American Medical Association, 371 male and female alcoholics, all of whom were drinking heavily at the time of entering the trial, were randomly selected to take topiramate (up to 300 mg/day) or placebo. All of them had a weekly 15-minute intervention with a trained nurse to enhance adherence to the medication and treatment regimen. Topiramate was previously approved by the Food and Drug Administration for seizures and migraine headaches and is manufactured by Ortho-McNeil Neurologics, Inc. Topiramate is not currently approved for the treatment of alcohol dependence.

Researchers approached the results as conservatively as possible, counting all dropouts or people who missed appointments as subjects who relapsed to their baseline drinking level. Even so, topiramate lowered the percentage of heavy drinking days (the number of days in which men and women consumed ≥5 drinks/day and ≥4 drinks/day, respectively, divided by the number of study days) by a mean of 8.44% more than placebo. The topiramate group had a reduction from 82% to a mean of 44% heavy drinking days during the 14 weeks, while the placebo group had a reduction from 82% to a mean of 52% heavy drinking days.

In a second analysis that tested the study hypothesis for all randomized participants who took at least one study medication dose and had at least one double-blind site visit, topiramate was much more efficacious than placebo, lowering the percentage of heavy drinking days by a mean of 16.19% more than placebo.

Additionally, for all secondary measures of self-reported drinking and the laboratory marker for drinking, gamma-glutamyltransferase in plasma, topiramate was more efficacious than placebo, according to both sets of analysis.

Importantly, both of these sets of analysis demonstrate the consistency and robustness of topiramate's efficacy over placebo in treating alcohol dependence. Furthermore, this trial demonstrates that alcoholics who are drinking severely can begin to receive a safe and efficacious medicine immediately without having to undergo detoxification or stop drinking first--an important paradigm shift.

Ortho-McNeil Janssen Scientific Affairs provided the study medication, topiramate, and funding for this study.
Prof. Johnson's previous work with topiramate was featured this year in the HBO documentary, "Addiction", which in September won the prestigious Governor's Award, a Special Emmy Award, from the Academy of Television Arts & Sciences. To view the portion of that documentary that features patients taking topiramate for alcohol dependence, go to:

For more information about topiramate, please visit

University of Virginia Health System

Related Alcohol Dependence Articles from Brightsurf:

Three genes predict success of naltrexone in alcohol dependence treatment
Of patients who seek treatment for alcohol use disorder, 60% to 80% relapse within a year.

In mice, alcohol dependence results in brain-wide remodeling of functional architecture
Using novel imaging technologies, researchers produce first whole-brain atlas at single-cell resolution, revealing how alcohol addiction and abstinence remodel neural physiology and function in mice.

Years of education may impact drinking behavior and risk of alcohol dependence
Higher educational attainment -- spending more years in education -- may impact people's drinking behavior and reduce their risk of alcohol dependence, according to a study published in Molecular Psychiatry.

Potential novel biomarker for alcohol dependence
Specific molecules (small noncoding microRNAs or miRNAs) found in saliva may be able to predict alcohol dependence as biomarkers.

Alcohol dependence, psychiatric disorders share genetic links
An international team of researchers has identified a gene that regulates how quickly the body metabolizes alcohol as a key risk factor for alcohol dependence.

Opioid use may affect treatment for alcohol dependence
New research indicates that opioid misuse and the use of cannabis and other drugs may compromise the effectiveness of treatments for alcohol use disorder.

No magic pill to cure alcohol dependence yet
A new study published by the scientific journal Addiction has found no reliable evidence for using nalmefene, naltrexone, acamprosate, baclofen or topiramate to control drinking in patients with alcohol dependence or alcohol use disorder.

Drug used for alcohol dependence might also treat stuttering, suggest researchers
Baclofen, a drug that has recently been used to treat alcohol dependence despite not officially being licensed for this condition, might also help stop stuttering, suggest researchers in the journal BMJ Case Reports.

Surprising brain change appears to drive alcohol dependence
A new study led by scientists at The Scripps Research Institute (TSRI) could help researchers develop personalized treatments for alcoholism and alcohol use disorder.

Prescribing of baclofen for alcohol dependence 'should be reconsidered'
The drug baclofen has received high visibility as a possible breakthrough treatment for alcohol dependence.

Read More: Alcohol Dependence News and Alcohol Dependence Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to