NCT00768508

Combined Pharmacotherapies for Alcoholism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Bankole Johnson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.

Detailed description

We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy	Ondansetron 4 ug/kg b.i.d.for 12 weeks
DRUG	Naltrexone 50 mg/day + Cognitive Behavioral Therapy	Naltrexone 50 mg/day for 12 weeks
DRUG	Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy	Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks
OTHER	Placebo + Cognitive Behavioral Therapy	Placebo comparator

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-10-08
• Last updated: 2013-03-15

Locations

2 sites across 1 country: United States