Randomized, Double-Blind, Placebo-Controlled Trial of Varenicline to
Reduce Alcohol Consumption in Heavy Drinkers

EPISODE #2
Uploaded:  November 4, 2008
Running Time:  3:27

SCHMALFELDT: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO.

Sometimes, a medication that is shown to be effective in treating one medical condition is shown to have equally promising effects when applied toward treating a completely separate condition.  Researchers at the NIH Clinical Center have launched a study into a drug called varenicline.  They know it acts on the brain's nicotine receptors and is used to help smokers stop smoking.  Can it also help heavy drinkers cut back on their alcohol consumption?  That's the question principal investigator, Dr. Vijay Ramchandani from the National Institute of Alcoholism and Alcohol Abuse would like to answer.

RAMCHANDANI: Varenicline is being marketed for smoking cessation, and there is some interesting animal data from studies done in rodents that indicate it may be reducing drinking behaviors.  So we have now begun getting ready to start this study to see how it might change drinking behaviors in heavy drinkers.

SCHMALFELDT: For the purposes of this protocol, heavy drinkers are defined as people between 24 and 60 years of age who regularly consume 20 to 40 alcoholic drinks per week and are not currently seeking treatment for problems related to alcohol.  Dr. Ramchandani explained the protocol.

RAMCHANDANI: We would screen them through our standard protocol screening battery to assess their physical health and mental health.  And then, once they qualify for the protocol, they would complete a total of five visits.  So the first is a pre-study session where we will assess alcohol self-administration - how much alcohol they would be willing to consume in a free-choice type of experimental design.  Then they would start on varenicline for three weeks.  Each week, they would come back.  The first week is a clinical visit to make sure they are tolerating the drug and to assess some behavioral and mood states.  And at the end of the second week they come back and they do an fMRI experiment, which is magnetic resonance imaging, to look at brain function while they are receiving an infusion of alcohol.  And then at the end of the third week, they would come back and repeat the self-infusion session.

SCHMALFELDT: Dr. Ramchandani talked about what participants can expect after the study is completed.

RAMCHANDANI: Following the third week visit for the self-administration session, they go through two brief interventions where we talk to them about the alcohol use, their drinking behavior, and after the study is completed, we would share any information we have about what we have determined in terms of consequences of their alcohol drinking.

SCHMALFELDT: If you would like more information about clinical trials, log on to http://clinicalcenter.nih.gov, or e-mail prpl@mail.cc.nih.gov.  You may also call, toll free, 1-866-999-5553.  From America's Clinical Research Hospital, this has been Episode One of CLINICAL CENTER RADIO.  In Bethesda, Maryland, I'm Bill Schmalfeldt at the National Institutes of Health, an agency of the United States Department of Health and Human Services.

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