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  • Title: A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence.
    Author: Shearer J, Darke S, Rodgers C, Slade T, van Beek I, Lewis J, Brady D, McKetin R, Mattick RP, Wodak A.
    Journal: Addiction; 2009 Feb; 104(2):224-33. PubMed ID: 19149817.
    Abstract:
    AIM: To examine the safety and efficacy of modafinil (200 mg/day) compared to placebo in the treatment of methamphetamine dependence and to examine predictors of post-treatment outcome. PARTICIPANTS AND DESIGN: Eighty methamphetamine-dependent subjects in Sydney, Australia were allocated randomly to modafinil (200 mg/day) (n = 38) or placebo (n = 42) under double-blind conditions for 10 weeks with a further 12 weeks post-treatment follow-up. MEASURES: Comprehensive drug use data (urine specimens and self-report) and other health and psychosocial data were collected weekly during treatment and research interviews at baseline, week 10 and week 22. RESULTS: Treatment retention and medication adherence were equivalent between groups. There were no differences in methamphetamine abstinence, craving or severity of dependence. Medication-compliant subjects tended to provide more methamphetamine-negative urine samples over the 10-week treatment period (P = 0.07). Outcomes were better for methamphetamine-dependent subjects with no other substance dependence and those who accessed counselling. There were statistically significant reductions in systolic blood pressure (P = 0.03) and weight gain (P = 0.05) in modafinil-compliant subjects compared to placebo. There were no medication-related serious adverse events. Adverse events were generally mild and consistent with known pharmacological effects. CONCLUSIONS: Modafinil demonstrated promise in reducing methamphetamine use in selected methamphetamine-dependent patients. The study findings support definitive trials of modafinil in larger multi-site trials.
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