CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Acamprosate +1 moredrug
Likely dose
Acamprosate 333 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00571922
NCT00571922Phase 2Completed
CompareCT.gov

A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence

NYU Langone Health·interventional·Posted Dec 12, 2007·Updated Mar 24, 2017

In Brief

A Phase 2 clinical trial evaluating Acamprosate and placebo for Methamphetamine Dependence, Treatment Seeking. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMethamphetamine Dependence, Treatment Seeking
CountriesUnited States
CollaboratorsForest Laboratories

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2007
Enrollment StartJul 1, 2007
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.6 years ago

Interventions

Acamprosatedrug

2 gr/day (333 mg, TID)

placebodrug

matching placebo