CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Modafinil +2 moredrug
Likely dose
Modafinil 200mg or 400mg (plus cognitive behavioral therapy)AI-extracted
Key inclusion· 3
  • ✓Seeking treatment for cocaine dependence
  • ✓Meets DSM-IV diagnosis criteria for cocaine dependence by Mini-SCID interview
  • ✓Lives within 50 miles of the research center with reliable transportation
Key exclusion· 14
  • ✕Meets DSM-IV criteria for dependence on drugs other than cocaine, alcohol, nicotine, or marijuana
  • ✕Physiologic dependence on alcohol requiring medical detoxification
  • ✕Current psychiatric disorder: depression, schizophrenia, bipolar disorder, organic brain disease, dementia, or psychosis
  • ✕Recent suicidal or homicidal attempts within 60 days, or ideation within 30 days

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

Search/NCT00218387
NCT00218387Phase 2Completed
CompareCT.gov

CBT and Modafinil for Cocaine Addiction

Medical University of South Carolina·interventional·Posted Sep 22, 2005·Updated Apr 10, 2019

In Brief

A Phase 2 clinical trial evaluating Modafinil and Matching Placebo for Cocaine Dependence. Completed, enrolled 123 participants across 1 site.

Detailed Summary

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartApr 1, 2004
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago

Interventions

Modafinildrug

200mg Modafinil

Modafinildrug

400mg Modafinil

Matching Placebodrug

Matching Placebo