CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 114 enrolled
Drug / intervention
Modafinil +1 moredrug
Likely dose
Modafinil 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01137396
NCT01137396Phase 2Completed

Modafinil, Sleep Architecture and Cocaine Relapse

Yale University·interventional·Posted Jun 4, 2010·Updated Apr 27, 2016

In Brief

A Phase 2 clinical trial evaluating Modafinil and Cognitive Behavioral Therapy for Cocaine Dependence. Completed, enrolled 114 participants across 1 site.

Detailed Summary

The medication modafinil has been shown to reduce cocaine use in some cocaine users. The investigators have shown that modafinil taken in the morning improves sleep in chronic cocaine users. The investigators hypothesize that the beneficial effects of modafinil in reducing cocaine use may be related to specific effects modafinil has on sleep. This study will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2010
Enrollment StartApr 1, 2010
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.1 years ago

Interventions

Modafinildrug

Modafinil 400mg PO QDaily following up-titration for \~8weeks

Cognitive Behavioral Therapybehavioral

Once weekly cognitive behavioral therapy for cocaine dependence