CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 210 enrolled
Drug / intervention
Low Dose Modafinil +2 moredrug
Likely dose
Modafinil 200 mg/day (low dose) or 400 mg/day (high dose) orallyAI-extracted
Key inclusion· 3
  • ✓Age 18-60 years
  • ✓Current DSM-IV diagnosis of cocaine dependence
  • ✓Used at least $200 worth of cocaine within past 30 days with positive urine toxicology (benzoylecgonine/BE)
Key exclusion· 9
  • ✕Dependent on any substance other than cocaine or nicotine
  • ✕Neurological or psychiatric disorders including psychosis, bipolar illness, organic brain disease, dementia, or disorders requiring psychotropic medications
  • ✕Serious medical illnesses including uncontrolled hypertension, significant heart disease (MI history, angina, mitral valve prolapse, LVH, palpitations, arrhythmia), hepatic disease, renal disease, or serious progressive conditions
  • ✕Gastrointestinal, liver, or kidney disease causing altered metabolism/excretion, including history of major GI surgery or chronic GI disorders

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

Search/NCT00129285
NCT00129285Phase 2Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled Study of Modafinil for Cocaine Dependence

University of Pennsylvania·interventional·Posted Aug 11, 2005·Updated May 8, 2018

In Brief

A Phase 2 clinical trial evaluating Low Dose Modafinil, High Dose Modafinil, and 1 other intervention for Cocaine-Related Disorders. Completed, enrolled 210 participants across 1 site.

Detailed Summary

Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2005
Enrollment StartJul 1, 2004
Primary CompletionJan 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.9 years ago

Interventions

Low Dose Modafinildrug

modafinil 200 mg/day

High Dose Modafinildrug

modafinil 400 mg/day

Placebodrug

placebo 400 mg/day