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


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.
Turning Point Alcohol and Drug Centre, Melbourne, Australia.
Nicole
N
Lee
Amy
A
Pennay
Robert
R
Hester
Rebecca
R
McKetin
Suzi
S
Nielsen
Jason
J
Ferris
D000328:Adult; D019969:Amphetamine-Related Disorders / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008694:Methamphetamine / Q000009:adverse effects*; D008875:Middle Aged; D000077408:Modafinil; D010865:Pilot Projects; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D016896:Treatment Outcome; D055815:Young Adult
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D008694:Methamphetamine; D000077408:Modafinil