A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: Forest Laboratories
• Treatments: Acamprosate; Methamphetamine

Criteria

Inclusion Criteria:

• Methamphetamine dependence

• Treatment seeking

• Urine sample (+) for methamphetamine

Exclusion Criteria:

• Pregnancy

• Dependence on other drugs (except nicotine)

• DSM-IV axis I disorder unrelated to drug abuse

• Serious medical condition in clinicians opinion.

• AIDs

• Untreated syphilis

• Allergy to acamprosate

• Methadone, or other ORP, maintenance