CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Acamprosate +3 moredrug
Likely dose
Acamprosate 333mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00605904
NCT00605904Phase 2Completed

Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics

National Institute on Alcohol Abuse and Alcoholism (NIAAA)·interventional·Posted Jan 31, 2008·Updated Jul 3, 2012

In Brief

A Phase 2 clinical trial evaluating Acamprosate, Yohimbine, and 2 other interventions for Alcoholism. Completed, enrolled 37 participants across 1 site.

Detailed 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....

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2008
Enrollment StartJan 1, 2008
Primary CompletionSep 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.4 years ago

Interventions

Acamprosatedrug

orally administered tablet, 333mg, three times daily for a minimum of 2 weeks (14 days)

Yohimbinedrug

Intravenous infusion of yohimbine (0.4 mg/kg) administered once over 10 minutes

mCPPdrug

Intravenous infusion of mCPP (0.05 mg/kg) over 10 minutes, two times, for a total of 0.1 mg/kg

Salinedrug

Intravenous infusion of 0.9% sodium chloride solution over 10 minutes, three times during the study (2 times for the "Saline Infusion" milestone, and one time immediately following the "Yohimbine Infusion" milestone)