A pilot randomised controlled trial of modafinil during acute methamphetamine withdrawal: Feasibility, tolerability and clinical outcomes Academic Article uri icon


  • INTRODUCTION AND AIMS: There are no medications approved for the treatment of methamphetamine withdrawal. Wake-promoting agent modafinil has recently been proposed as a viable option. This paper reports on the results of a pilot study that tested the feasibility of modafinil in an inpatient withdrawal setting during acute methamphetamine withdrawal. DESIGN AND METHODS: In a double-blind, randomised, placebo-controlled study, 19 methamphetamine dependent participants received modafinil (n = 9) or placebo (n = 10) daily for 7 days (200 mg for the first 5 days and 100 mg on days 6 and 7). Primary outcomes were retention in treatment and severity of withdrawal symptoms. Secondary outcomes were methamphetamine craving, sleep and physiological outcomes. RESULTS: There were no significant differences between groups on retention in treatment, withdrawal severity, craving, sleep or physiological outcomes. There were no adverse events or side-effects reported. CONCLUSIONS: Modafinil was found to be tolerable and well accepted by methamphetamine users and feasible for short-term inpatient withdrawal, but the sample was too small to detect treatment effects. Larger trials are needed to establish efficacy.


  • Lee, N
  • Pennay, A
  • Hester, R
  • Mcketin, R
  • Nielsen, S
  • Ferris, J

publication date

  • 2013