Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals

Phase 2 Completed 73 enrolled The University of Texas Health Science Center, Houston National Institute on Drug Abuse (NIDA) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2006-03
Primary completion: 2012-01
Completion: 2012-01

Outcome

Missed primary endpoint

paper Retention rates did not differ between groups and were generally low, with 40% remaining in treatment at week 12 and 20% at week 16. PMID 22969732 ↗

paper Participants receiving the combination of modafinil and d-amphetamine showed a trend of increased cocaine use over time with a corresponding low Bayesian probability of benefit (33%). PMID 22969732 ↗

Publications

Results Schmitz JM, Rathnayaka N, Green CE, Moeller FG, Dougherty AE, Grabowski J. Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation. Front Psychiatry. 2012 Aug 30;3:77. doi: 10.3389/fpsyt.2012.00077. eCollection 2012.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dextroamphetamine	Small molecule	30 mg	—
Subject	Dextroamphetamine	Small molecule	60 mg	—
Subject	Modafinil	Small molecule	200 mg	—
Subject	Modafinil	Small molecule	400 mg	—