A pilot randomised controlled trial of modafinil during acute methamphetamine withdrawal: feasibility, tolerability and clinical outcomes

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 7days (200mg for the first 5days and 100mg 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