A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence.
OBJECTIVE
To examine the safety and efficacy of modafinil (200 mg/day) compared to placebo in the treatment of methamphetamine dependence and to examine predictors of post-treatment outcome.


METHODS
Eighty methamphetamine-dependent subjects in Sydney, Australia were allocated randomly to modafinil (200 mg/day) (n = 38) or placebo (n = 42) under double-blind conditions for 10 weeks with a further 12 weeks post-treatment follow-up.


METHODS
Comprehensive drug use data (urine specimens and self-report) and other health and psychosocial data were collected weekly during treatment and research interviews at baseline, week 10 and week 22.


RESULTS
Treatment retention and medication adherence were equivalent between groups. There were no differences in methamphetamine abstinence, craving or severity of dependence. Medication-compliant subjects tended to provide more methamphetamine-negative urine samples over the 10-week treatment period (P = 0.07). Outcomes were better for methamphetamine-dependent subjects with no other substance dependence and those who accessed counselling. There were statistically significant reductions in systolic blood pressure (P = 0.03) and weight gain (P = 0.05) in modafinil-compliant subjects compared to placebo. There were no medication-related serious adverse events. Adverse events were generally mild and consistent with known pharmacological effects.


CONCLUSIONS
Modafinil demonstrated promise in reducing methamphetamine use in selected methamphetamine-dependent patients. The study findings support definitive trials of modafinil in larger multi-site trials.
Shearer
James
J
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
Darke
Shane
S
Rodgers
Craig
C
Slade
Tim
T
van Beek
Ingrid
I
Lewis
John
J
Brady
Donna
D
McKetin
Rebecca
R
Mattick
Richard P
RP
Wodak
Alex
A
D000328:Adult; D019969:Amphetamine-Related Disorders / Q000517:prevention & control / Q000534:rehabilitation*; D001315:Australia; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D012008:Recurrence; D012720:Severity of Illness Index; D015813:Substance Abuse Detection; D016896:Treatment Outcome; D055815:Young Adult
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil