CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
D-Amphetamine 30mg +5 moredrug
Likely dose
D-Amphetamine 30-60 mg or Modafinil 200-400 mg dailyAI-extracted
Key inclusion· 3
  • Meets SCID criteria for cocaine abuse or dependence
  • In general good health
  • HIV-positive participants allowed if in good health and no medication interactions
Key exclusion· 5
  • Meets diagnostic criteria for other psychiatric disorders or drug dependence (except nicotine)
  • Current cardiovascular disease as determined by electrocardiogram
  • On probation or parole if circumstances do not allow study completion or confidentiality cannot be maintained
  • Previously received treatment with d-amphetamine, modafinil, or aripiprazole

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

Search/NCT00218062
NCT00218062Phase 2Completed

Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)

The University of Texas Health Science Center, Houston·interventional·Posted Sep 22, 2005·Updated Jun 21, 2017

In Brief

A Phase 2 clinical trial evaluating D-Amphetamine 30mg, D-Amphetamine 60mg, and 4 other interventions for Cocaine-Related Disorders. Completed, enrolled 73 participants across 1 site.

Detailed Summary

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartMar 1, 2006
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

Interventions

D-Amphetamine 30mgdrug

D-Amphetamine 60mgdrug

Modafinil 200mgdrug

Modafinil 400mgdrug

Therapybehavioral

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Placebodrug