Phase 2
N=72
A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction
Methamphetamine Dependence, Treatment Seeking
Bottom Line
View on ClinicalTrials.gov: NCT00571922 ↗Enrolled (actual)
72
Serious AEs
—
Results posted
Apr 2016
Primary outcome: Primary: Methamphetamine Abstinence
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acamprosate (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Methamphetamine Abstinence |
— | — |
| SECONDARY Craving |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00571922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.