title: A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence.
abstract: 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.
authors.affiliation: National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
authors.forename: James
authors.initials: J
authors.lastname: Shearer
authors.forename: Shane
authors.initials: S
authors.lastname: Darke
authors.forename: Craig
authors.initials: C
authors.lastname: Rodgers
authors.forename: Tim
authors.initials: T
authors.lastname: Slade
authors.forename: Ingrid
authors.initials: I
authors.lastname: van Beek
authors.forename: John
authors.initials: J
authors.lastname: Lewis
authors.forename: Donna
authors.initials: D
authors.lastname: Brady
authors.forename: Rebecca
authors.initials: R
authors.lastname: McKetin
authors.forename: Richard P
authors.initials: RP
authors.lastname: Mattick
authors.forename: Alex
authors.initials: A
authors.lastname: Wodak
mesh_terms: 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
chemical_list: D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil