CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
Modafinil +2 moredrug
Likely dose
Modafinil 300 mg once daily for 8 weeksAI-extracted
Key inclusion· 5
  • ✓Age 18-60 years
  • ✓Current DSM-IV diagnosis of cocaine dependence
  • ✓Active cocaine use: at least 8 days in a consecutive 30-day period over the 60 days before study entry (or before inpatient treatment admission if applicable)
  • ✓Negative benzoylecgonine (cocaine metabolite) urine test at screening (≥5 days before randomization) AND on day of randomization
Key exclusion· 10
  • ✕Currently dependent on any substance other than cocaine or nicotine
  • ✕Current neurological or psychiatric disorders including psychosis, bipolar illness, organic brain disease, dementia, or any requiring psychotropic medications
  • ✕Serious medical illnesses: uncontrolled hypertension, significant heart disease (MI history, angina, mitral valve prolapse, LVH, palpitations, arrhythmia), hepatic disease, renal disease, or serious progressive medical illness compromising safety
  • ✕Receipt of organ-toxic drugs within prior month (chemotherapy agents, parasitic infection agents, isoniazid, immunosuppressives, protease inhibitors, amphotericin B, cephalosporins, aminoglycosides, interferon, sulfonamides)

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

Search/NCT00368290
NCT00368290Phase 2Completed
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Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior

Kyle Kampman·interventional·Posted Aug 24, 2006·Updated Mar 15, 2018

In Brief

A Phase 2 clinical trial evaluating Modafinil, placebo, and 1 other intervention for Cocaine Dependence. Completed, enrolled 94 participants.

Detailed Summary

The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces high risk behavior in cocaine dependent subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Dependence
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2006
Enrollment StartSep 1, 2006
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 19.9 years ago

Interventions

Modafinildrug

300mg a day for 8 weeks

placebodrug

placebo pills for 8 weeks

Cognitive Behavioral Therapy (CBT)behavioral

Weekly cognitive behavioral therapy sessions for a period of 8 weeks.