drugset / Trial / NCT00260481

Prometa Pharmacotherapy for Methamphetamine Dependence

NCT00260481

Phase 2/3 Completed 120 enrolled University of California, Los Angeles
RandomizedSingle-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess the efficacy of the PROMETA pharmacotherapy compared to placebo for initiating abstinence and for preventing relapse to methamphetamine use in treatment-seeking individuals meeting criteria for methamphetamine abuse. It is hypothesized that individuals assigned to receive the PROMETA pharmacotherapy, compared to placebo, will demonstrate significantly fewer and less intense withdrawal symptoms, more days abstinent from methamphetamine use, and fewer relapses to methamphetamine use as assessed by self-report of drug use verified by urine samples.

Timeline

Start
2006-01
Primary completion
2008-06
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Flumazenil Small molecule 2 mg Intravenous
Comparator Gabapentin Small molecule 1200 mg Oral
Comparator Hydroxyzine Small molecule 50 mg Oral