NCT00360594

Acamprosate Initiated During Alcohol Detoxification

Initiating Acamprosate Within Versus Post-detoxification in the Rehabilitative Treatment of Alcohol Dependence.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol detoxification instead of waiting until detoxification has been completed effects the course of detoxification, adverse events during detoxification, drop out rate during the rehabilitative treatment phase, or overall efficacy of acamprosate for those with alcohol dependence who plan to receive at least two months of rehabilitative pharmacotherapy with acamprosate.

Detailed description

Biphasic clinical trial, consisting of a randomized, double-blind, placebo-controlled detoxification treatment phase (DP), followed by 9-week open-label rehabilitative treatment phase (RP).

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Acamprosate	3 pills (666 mg) for 1998mg/day
DRUG	Placebo	3 pills (666mg) for 1998mg/day

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-09-01
• Completion: 2007-11-01
• First posted: 2006-08-04
• Last updated: 2017-01-11

Locations

1 site across 1 country: United States