A pilot randomised controlled trial of modafinil during acute methamphetamine withdrawal: Feasibility, tolerability and clinical outcomes
- Clinical Trial Registration: Australian New Zealand Clinical Trials Registry—ACTRN12606000272594
Nicole Lee PhD, Associate Professor, Amy Pennay BA (Hons), Research Fellow, Robert Hester PhD, Senior Research Fellow, Rebecca McKetin PhD, Senior Research Fellow, Suzi Nielsen PhD, Senior Research Fellow, Jason Ferris MBioStats, Senior Statistician. Correspondence to Miss Amy Pennay, Turning Point Alcohol and Drug Centre, 54-62 Gertrude Street, Fitzroy, Vic. 3065, Australia. Tel: +61 3 8413 8413; Fax: +61 3 9416 3420; E-mail: firstname.lastname@example.org
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.
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.
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.