A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction
Phase 1
Completed
- Conditions
- Methamphetamine Dependence, Treatment Seeking
- Interventions
- Drug: placebo
- Registration Number
- NCT00571922
- Lead Sponsor
- NYU Langone Health
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Acamprosate Acamprosate -
- Primary Outcome Measures
Name Time Method Methamphetamine Abstinence 7 day
- Secondary Outcome Measures
Name Time Method Craving 7 day
Trial Locations
- Locations (1)
VA New York Harbor Healthcare System, MHAD clinic
🇺🇸New York, New York, United States