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 withdraw...

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Bibliographic Details
Main Authors: Lee, N., Pennay, A., Hester, R., McKetin, Rebecca, Nielsen, S., Ferris, J.
Format: Journal Article
Published: Wiley-Blackwell Publishing Ltd. 2013
Online Access:http://hdl.handle.net/20.500.11937/56651
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Summary: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. Second ary 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.