Vigabatrin for the Treatment of Cocaine Dependency

Status Completed

Clinical Trial Summary

Clinical Trial Description

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

There are 3 Phases to this study:

- a 2-4 week Screening/Baseline Phase during which eligibility to be included in the trial will be tested;

- a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling; and

- a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects will continue to receive counseling. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01281202
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	January 2011
Completion date	December 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04994821` - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study	Phase 2
Completed	`NCT01601743` - Exercise as a Behavioral Treatment for Cocaine Dependence	N/A
Completed	`NCT01402492` - Cocaine Use Reduction With Buprenorphine	Phase 2/Phase 3
Completed	`NCT01176591` - HBPL Study of the Impact of the NK1 Antagonist Aprepitant	Phase 2
Completed	`NCT00880997` - The Efficacy of Doxazosin for Cocaine Users	Phase 1
Completed	`NCT00566969` - Cocaine Withdrawal and Pharmacotherapy Response	N/A
Completed	`NCT00585520` - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues	Phase 1
Completed	`NCT00368290` - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior	Phase 2
Completed	`NCT00322309` - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects	Phase 2
Completed	`NCT00385801` - Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence	Phase 2
Completed	`NCT00167245` - Topiramate for Alcohol and Cocaine Dependence	Phase 2
Completed	`NCT00842517` - Long Term Maintenance of Drug Abstinence	Phase 1
Completed	`NCT04411914` - Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid	Phase 1
Active, not recruiting	`NCT03266939` - Rebalancing the Serotonergic System in Cocaine Dependence	Phase 1
Completed	`NCT02563769` - Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study	Phase 1
Recruiting	`NCT06159387` - Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts	Phase 4
Terminated	`NCT02935101` - Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants	Phase 2
Completed	`NCT02018263` - Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans	Phase 1
Completed	`NCT01573273` - Oxytocin in Cocaine Dependence	N/A
Withdrawn	`NCT01406522` - Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics	Phase 2