NCT03090269

Methylphenidate for Cocaine Dependence

Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This phase II pilot study aims at evaluating the benefits and the risks of methylphenidate (Concerta®) for the treatment of cocaine/crack dependence in terms of cocaine/crack use reduction and adverse events.

Detailed description

Patients will receive pharmacotherapy based on methylphenidate (18 mg per tablet) with a 3-week titration phase to a maximum dose of 108 mg per day, with a weekly follow-up during 3 months. Socio-demographic and behavioral data will be collected through phone interviews every month. During medical visits, self-administered and clinical questionnaires will collect clinical and behavioral data. Urine drug toxicologies and blood sampling will be performed to gather biological, pharmacokinetic and pharmacodynamic data. This study should identify an effective response-dose of methylphenidate for people with a cocaine use disorder. The methylphenidate should be effective to reduce cocaine use in cocaine-dependent individuals with a good tolerability. The results of pharmacokinetic and pharmacodynamic analyses will give us the effective dose of methylphenidate and some information on toxicity to adapt the surveillance in a future clinical trial.

Conditions

• Substance-Related Disorders

Interventions

Type	Name	Description
DRUG	Methylphenidate Pill	3-month follow-up to study the effective dose as a treatment for cocaine dependence in toxicity and reduction in cocaine use

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-12-31
• Completion: 2019-03-30
• First posted: 2017-03-24
• Last updated: 2018-07-20

Locations

1 site across 1 country: France