CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 250 enrolled
Drug / intervention
topiramate +2 moredrug
Likely dose
topiramate 0mgfrom 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/NCT00685178
NCT00685178Phase 2Completed

Clinical Trial of Topiramate for Cocaine Addiction

Johns Hopkins University·interventional·Posted May 28, 2008·Updated Jul 11, 2017

In Brief

A Phase 2 clinical trial evaluating topiramate, Contingency Reinforcement, and 1 other intervention for Cocaine Dependence. Completed, enrolled 250 participants across 1 site.

Detailed Summary

This is an outpatient clinical trial of topiramate for addressing cocaine dependence and reduction of cocaine associated behaviors in opiate dependent drug users maintained on methadone treatment. The study aims to answer whether topiramate 1. is safe and acceptable to methadone patients 2. reduces cocaine use 3. helps with collateral problems such as alcohol abuse, tobacco dependence, anxiety, PTSD and/or pain symptoms. The study will also evaluate topiramate effect on neuro-cognitive performance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 28, 2008
Enrollment StartFeb 1, 2007
Primary CompletionJun 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.1 years ago

Interventions

topiramatedrug

topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day. capsules are administered from week 4 through 25 of the trial

Contingency Reinforcementbehavioral

monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results

placebo + NonCRdrug

participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence