Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
Study NCT ID:
NCT03090269
Status:
WITHDRAWN
Last Update Posted:
2018-07-20
First Post:
2017-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Methylphenidate for Cocaine Dependence
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
Official Title:
Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence
Status:
WITHDRAWN
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
feasibility reasons.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANRS STIMAGO
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-002996-16 | EUDRACT_NUMBER | None | View |