Trial intelligence / Profile preview

Tiagabine for Cocaine Dependence in Methadone Patients

NCT00129298Phase 2

Key facts

Status: Completed
Start: Dec 2004
Sponsor: National Institute on Drug Abuse
Modality: Small Molecules

Drugs: tiagabine
Conditions: cocaine dependence

Overview

Phase 2, randomised, double-blind trial in cocaine dependence comparing Tiagabine with Placebo (2 arms). Primary endpoint: Thrice weekly Urine toxicology at 13 weeks. Started Dec 2004; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Tiagabine
Tiagabine (titrated to 32mg/day) + Methadone
Placebo
Placebo + Methadone

Who it enrols

Inclusion: Opioid dependence (1 year history, positive urine), Cocaine abuse (>1/week, positive urine, SDS >3). Exclusion: Other drug dependence, serious medical/psychiatric illness, psychotropic meds, pregnancy.

Endpoints

Primary

Thrice weekly Urine toxicology13 weeks

Secondary

Self reports of cocaine and opioid use13 weeks
Opioid withdrawal symptoms13 weeks
Adverse events13 weeks
cocaine craving13 weeks

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