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NIDA-CSP-1025

Division

DTMC

HEAL Study

Investigator(s)

Bankole Johnson, DSc., M.D., Ph.D.

Title

Phase 2, Double-Blind, Placebo-Controlled Trial Of Topiramate For The Treatment Of Methamphetamine Dependence

Short Description

The objectives of this study are to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.

Release Date

Sep 02, 2015

Description

The primary efficacy objective of this study is to determine if topiramate relative to placebo reduces methamphetamine use in subjects with methamphetamine dependence as measured by quantitative urinalysis for methamphetamine. The primary efficacy outcome measure is negative methamphetamine use weeks during study Weeks 6 through 12. Data collected during this phase of treatment will be the focus of the primary outcome measure as this is the time period in which the subject will be treated with the maintenance dose of topiramate.

Keywords

Assessments

Addiction Severity Index Lite

Brief Substance Craving Scale

Clinical Global Impression Scales

HIV Risk-Taking Behaviour Scale

Substance Use Report

Urine Methamphetamine Level