Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
This study will determine if acamprosate, a drug approved to treat alcoholism, decreases
alcohol cravings in alcohol-dependent subjects following infusions of yohimbine and mCPP.
Yohimbine causes anxiety and may provoke a desire for alcohol; mCPP induces a feeling of
having had a few drinks, which often creates a desire for more drinks. If acamprosate can
prevent a craving following these stimuli, then the effectiveness of new experimental drugs
for treating alcoholism can be tested for their ability to block yohimbine or mCPP-induced
cravings. This type of investigation would be less expensive and less time-consuming than
conducting clinical trials with alcohol-dependent people.
People between 21 and 65 years of age who are alcohol-dependent and have been drinking
regularly for at least 1 month before entering the study may be eligible to participate.
Participants are admitted to the NIH Clinical Center for about 35 days, during which time
they are asked to participate in an alcohol treatment program. They may request passes to
leave the hospital during the day but must return overnight. Upon return to the hospital,
subjects are required to take a breathalyzer test for alcohol and urine screen for drug use.
Participants found to have used drugs or consumed alcohol while away from the hospital are
terminated from the study.
Participants are randomly assigned to take acamprosate or placebo pills three times a day for
about 2 weeks. They are then given three intravenous (through a vein) infusions, 5 to 7 days
apart, each containing either yohimbine, mCPP or placebo. The drugs are infused for 20
minutes following a 1-hour infusion of saline (salt water). Subjects complete two
questionnaires - an alcohol urge questionnaire to assess the desire for alcohol and a PASS
rating scale to assess anxiety - several times during the study and during the infusions....
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)