MedTrace Logo

Clinical Trial of Topiramate for Cocaine Addiction

NCT00685178 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2017-07-11

Study results available
· View outcomes & findings →

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.

Conditions

  • Cocaine Dependence

Interventions

DRUG

topiramate

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

BEHAVIORAL

Contingency Reinforcement

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

DRUG

placebo + NonCR

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

Sponsors & Collaborators

Principal Investigators

  • Annie Umbricht, M.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00685178 on ClinicalTrials.gov