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Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation.
Schmitz, Joy M; Rathnayaka, Nuvan; Green, Charles E; Moeller, F Gerard; Dougherty, Anne E; Grabowski, John.
Afiliación
  • Schmitz JM; Department of Psychiatry and Behavioral Sciences, University of Texas Houston, TX, USA.
Front Psychiatry ; 3: 77, 2012.
Article en En | MEDLINE | ID: mdl-22969732
ABSTRACT

BACKGROUND:

Two stimulant medications, modafinil and d-amphetamine, when tested individually, have shown safety and efficacy for treatment of cocaine addiction. We hypothesized that the combination of modafinil and d-amphetamine, at low doses, would show equivalent or greater benefit in reducing cocaine use compared to higher doses of each individual medication or placebo.

METHODS:

Sixteen week, randomized, parallel-group design with four treatment arms comparing placebo to modafinil 400 mg; d-amphetamine 60 mg; modafinil 200 mg plus d-amphetamine 30 mg. Primary outcome variables, retention and cocaine use, were analyzed on the sample of 73 participants who received the first dose of the study medication.

RESULTS:

Retention rates did not differ between groups and were generally low, with 40% remaining in treatment at week 12 and 20% at week 16. 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%). Relatively better cocaine outcomes were observed in the placebo and d-amphetamine only groups. The study medications were generally well-tolerated with few adverse effects, yet rates of adherence were suboptimal (≤80%).

CONCLUSION:

Data from this preliminary investigation fail to provide evidential support for conducting a larger study of this dual-agonist medication combination for treatment of cocaine dependence.
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Texto completo: 1 Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Front Psychiatry Año: 2012 Tipo del documento: Article

Texto completo: 1 Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Front Psychiatry Año: 2012 Tipo del documento: Article