CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Modafinil 0 mg +6 moredrug
Likely dose
Modafinil 0 mgfrom 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/NCT01778010
NCT01778010Phase 2Completed
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Modafinil in a Human Laboratory Model of Cocaine Relapse

New York State Psychiatric Institute·interventional·Posted Jan 29, 2013·Updated Jan 9, 2018

In Brief

A Phase 2 clinical trial evaluating Modafinil 0 mg, Modafinil 200 mg, and 5 other interventions for Cocaine Dependence. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2013
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 13.4 years ago

Interventions

Modafinil 0 mgdrug

Modafinil (0 mg/day)

Modafinil 200 mgdrug

Modafinil (200 mg/day)

Modafinil 400 mgdrug

Modafinil (400 mg/day)

Cocaine 0 mgdrug

Cocaine (0 mg/day)

Cocaine 12 mgdrug

Cocaine (12 mg/day)

Cocaine 25 mgdrug

Cocaine (25 mg/day)

Cocaine 50 mgdrug

Cocaine (50 mg/day)