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

Drug Alcohol Rev. 2013 Jan;32(1):88-95. doi: 10.1111/j.1465-3362.2012.00473.x. Epub 2012 May 27.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amphetamine-Related Disorders / drug therapy*
  • Amphetamine-Related Disorders / epidemiology
  • Amphetamine-Related Disorders / psychology
  • Benzhydryl Compounds / adverse effects
  • Benzhydryl Compounds / therapeutic use*
  • Central Nervous System Stimulants / adverse effects
  • Central Nervous System Stimulants / therapeutic use*
  • Double-Blind Method
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Methamphetamine / adverse effects*
  • Middle Aged
  • Modafinil
  • Pilot Projects
  • Substance Withdrawal Syndrome / drug therapy*
  • Substance Withdrawal Syndrome / epidemiology
  • Substance Withdrawal Syndrome / psychology
  • Treatment Outcome
  • Young Adult

Substances

  • Benzhydryl Compounds
  • Central Nervous System Stimulants
  • Methamphetamine
  • Modafinil