NCT00656630

Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: The Scripps Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence.

Detailed description

This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Acamprosate	Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
DRUG	Naltrexone	50mg capsule, Once daily, 1 week duration
DRUG	Placebo	Matched placebo capsule, 1 week duration

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-04-11
• Last updated: 2017-03-29
• Results posted: 2017-03-29

Locations

1 site across 1 country: United States