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Modafinil, Sleep Architecture and Cocaine Relapse

NCT01137396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2016-04-27

Study results available
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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.

Conditions

  • Cocaine Dependence

Interventions

DRUG

Modafinil

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

BEHAVIORAL

Cognitive Behavioral Therapy

Once weekly cognitive behavioral therapy for cocaine dependence

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Peter Morgan, MD, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137396 on ClinicalTrials.gov