Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Status Active, not recruiting

Clinical Trial Summary

The study aims to evaluate the safety and efficacy of modafinil (200 mg/day) over 10 weeks plus a tailored cognitive behavioural therapy program in the treatment of cocaine dependence.

Clinical Trial Description

Modafinil is a novel wake promoting agent approved in Australia for the treatment of narcolepsy. Preliminary studies have suggested that modafinil may have value in the treatment of psychostimulant dependence through positive effects on mood, sleep patterns, concentration, fatigue and drug craving. It appears to be well tolerated with a low abuse liability. Thirty dependent cocaine users will be randomised to 2 equal groups. The experimental group will receive modafinil 200 mg/day for 10 weeks and a tailored cognitive behavioural therapy program. The control group will receive placebo under equivalent conditions. Primary outcome will be a between group comparison of cocaine negative urine samples collected over the 10 week study period. Adverse events, side effects, compliance, retention, self reported health, psychosocial and drug use outcomes will also be compared between the groups. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00123383
Study type	Interventional
Source	The University of New South Wales
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	July 2005
Completion date	September 2007

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04994821` - tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study	Phase 2
Completed	`NCT01402492` - Cocaine Use Reduction With Buprenorphine	Phase 2/Phase 3
Completed	`NCT01601743` - Exercise as a Behavioral Treatment for Cocaine Dependence	N/A
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	`NCT00585520` - Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues	Phase 1
Completed	`NCT00566969` - Cocaine Withdrawal and Pharmacotherapy Response	N/A
Completed	`NCT00368290` - Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior	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	`NCT00322309` - Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects	Phase 2
Completed	`NCT00842517` - Long Term Maintenance of Drug Abstinence	Phase 1
Completed	`NCT00167245` - Topiramate for Alcohol and Cocaine Dependence	Phase 2
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