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. 2012 Aug 30:3:77.
doi: 10.3389/fpsyt.2012.00077. eCollection 2012.

Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation

Joy M Schmitz  1 , Nuvan Rathnayaka, Charles E Green, F Gerard Moeller, Anne E Dougherty, John Grabowski
Affiliations

Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation

Joy M Schmitz et al. Front Psychiatry. .

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.

Keywords: clinical trial; cocaine dependence; d-amphetamine; modafinil.

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Figures

Figure 1
Figure 1
Probability of cocaine use by medication condition and time.
See this image and copyright information in PMC

References

    1. Anderson A. L., Reid M. S., Li S. H., Holmes T., Shemanski L., Slee A., Smith E. V., Kahn R., Chiang N., Vocci F., Ciraulo D., Dackis C., Roache J. D., Salloum I. M., Somoza E., Urschel H. C., III, Elkashef A. M. (2009). Modafinil for the treatment of cocaine dependence. Drug Alcohol Depend. 104, 133–13910.1016/j.drugalcdep.2009.04.015 - DOI - PMC - PubMed
    1. Bayarri M. J., Berger J. O. (2004). The interplay of bayesian and frequentist analysis. Stat. Sci. 19, 58–8010.1214/088342304000000116 - DOI
    1. Businelle M. S., Rash C. J., Burke R. S., Parker J. D. (2009). Using vouchers to increase continuing care participation in veterans: does magnitude matter? Am. J. Addict. 18, 122–12910.1080/10550490802545125 - DOI - PubMed
    1. Carroll K. M., Fenton L. R., Ball S. A., Nich C., Frankforter T. L., Shi J., Rounsaville B. J. (2004). Efficacy of disulfiram and cognitive behavior therapy in cocaine-dependent outpatients: a randomized placebo-controlled trial. Arch. Gen. Psychiatry 61, 264–27210.1001/archpsyc.61.3.264 - DOI - PMC - PubMed
    1. Dackis C. A., Kampman K. M., Lynch K. G., Pettinati H. M., O’Brien C. P. (2005). A double-blind, placebo-controlled trial of modafinil for cocaine dependence. Neuropsychopharmacology 30, 205–21110.1038/sj.npp.1300701 - DOI - PubMed