NCT00183222

Effectiveness of Naltrexone and/or Ondansetron to Reduce Craving for Alcohol and Drinking

Alcohol Research Center Grant. Component #1. COMBINING MEDICATIONS: ALCOHOL REACTIVITY AND CONSUMPTION

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (planned)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence), ondansetron a serotonin 3 antagonist medication approved to treat nausea) or their combination are effective in the reduction of alcohol craving and drinking compared to placebo.

Detailed description

Non-treatment seeking individuals meeting criteria for alcohol dependence N=160) will be recruited through advertisement and paid for their participation. Alcoholics, after baseline evaluation, will be assigned through urn randomization (using a double dummy placebo controlled design) to one of four experimental groups, naltrexone (50 mg/day) (N=40), ondansetron (0.25 mg twice a day) (N=40), naltrexone and ondansetron (N=40) or placebos (N=40). Subjects will take the study drugs for 8 days (day 1-5 being the natural observation period). After a minimum of 48 hours of abstinence from alcohol day 6-8) they will undergo an alcohol administration (priming dose) and motivated free choice drinking procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end of the study to enhance their awareness of problem drinking and to motivate them to seek treatment. Referral for treatment will be offered.A subset of subjects from each medication group (N=15) will undergo a functional MRI brain scan with cue stimulation on day 7, on the evening before the alcohol administration paradigm. A smaller group of social drinker controls (N=16), recruited and paid in a similar fashion, will be randomly assigned to the same medication groups (4 per group). They will be used as procedure controls for the alcohol administration lab study and as a comparison/contrast group for the brain imaging sub-study.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	naltrexone (up to 50 mg/day) for 8 days; ondansetron (0.25 mg twice a day) for 8 days

Timeline

• Start date: 2005-05-01
• Completion: 2005-12-01
• First posted: 2005-09-16
• Last updated: 2010-05-05

Locations

1 site across 1 country: United States