Medication Development in Alcoholism: Acamprosate Versus Naltrexone
NCT00656630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2017-03-29
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.
Conditions
- Alcoholism
Interventions
- 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
-
Matched placebo capsule, 1 week duration
Sponsors & Collaborators
-
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH -
The Scripps Research Institute
lead OTHER
Principal Investigators
-
Barbara J Mason, Ph.D. · The Scripps Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Primary Completion
- 2010-01-31
- Completion
- 2010-01-31
Countries
- United States
Study Locations
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