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

Authors

  • Nicole Lee,

    1. Turning Point Alcohol and Drug Centre, Melbourne, Australia
    2. National Centre for Education and Training on Addiction, Flinders University, Adelaide, Australia
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    • Present address: The National Centre for Education and Training on Addiction, Flinders University, Adelaide, Australia.
  • Amy Pennay,

    Corresponding author
    1. Eastern Health Clinical School, Monash University, Melbourne, Australia
    • Turning Point Alcohol and Drug Centre, Melbourne, Australia
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  • Robert Hester,

    1. Department of Psychological Sciences, The University of Melbourne, Melbourne, Australia
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  • Rebecca McKetin,

    1. Centre for Research on Ageing, Health and Well-being, Australian National University, Canberra, Australia
    2. National Drug and Alcohol Research Centre, The University of New South Wales, Sydney, Australia
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    • Centre for Research on Ageing, Health and Well-being, Australian National University, Canberra, Australia.
  • Suzi Nielsen,

    1. Turning Point Alcohol and Drug Centre, Melbourne, Australia
    2. Discipline of Addiction Medicine, University of Sydney, Sydney, Australia
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    • Present address: Discipline of Addiction Medicine, University of Sydney, Sydney, Australia.
  • Jason Ferris

    1. Turning Point Alcohol and Drug Centre, Melbourne, Australia
    2. Institute for Social Science Research, The University of Queensland, Queensland, Australia
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    • Present address: Institute for Social Science Research, The University of Queensland, Queensland, Australia.

  • 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: amy.pennay@turningpoint.org.au

Abstract

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.

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