title: Modafinil for the treatment of methamphetamine dependence.
abstract: OBJECTIVE
  Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants, compared to placebo.
  
  
  METHODS
  This was a randomized, double-blind, placebo-controlled study, with 12 weeks of treatment and a 4-week follow-up. Eight outpatient substance abuse treatment clinics participated in the study. There were 210 treatment-seekers randomized, who all had a DSM-IV diagnosis of methamphetamine dependence; 68 participants to placebo, 72 to modafinil 200mg, and 70 to modafinil 400mg, taken once daily on awakening. Participants came to the clinic three times per week for assessments, urine drug screens, and group psychotherapy. The primary outcome measure was a methamphetamine non-use week, which required all the week's qualitative urine drug screens to be negative for methamphetamine.
  
  
  RESULTS
  Regression analysis showed no significant difference between either modafinil group (200 or 400mg) or placebo in change in weekly percentage having a methamphetamine non-use week over the 12-week treatment period (p=0.53). Similarly, a number of secondary outcomes did not show significant effects of modafinil. However, an ad-hoc analysis of medication compliance, by urinalysis for modafinil and its metabolite, did find a significant difference in maximum duration of abstinence (23 days vs. 10 days, p=0.003), between those having the top quartile of compliance (>85% of urines were positive for modafinil, N=36), and the lower three quartiles of modafinil 200 and 400mg groups (N=106).
  
  
  CONCLUSIONS
  Although these data suggest that modafinil, plus group behavioral therapy, was not effective for decreasing methamphetamine use, the study is probably inconclusive because of inadequate compliance with taking medication.
authors.affiliation: Division of Pharmacotherapies and Medical Consequences of Drug Abuse, National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD 20892-9551, United States. aa135m@nih.gov
authors.forename: Ann L
authors.initials: AL
authors.lastname: Anderson
authors.forename: Shou-Hua
authors.initials: SH
authors.lastname: Li
authors.forename: Kousick
authors.initials: K
authors.lastname: Biswas
authors.forename: Frances
authors.initials: F
authors.lastname: McSherry
authors.forename: Tyson
authors.initials: T
authors.lastname: Holmes
authors.forename: Erin
authors.initials: E
authors.lastname: Iturriaga
authors.forename: Roberta
authors.initials: R
authors.lastname: Kahn
authors.forename: Nora
authors.initials: N
authors.lastname: Chiang
authors.forename: Thomas
authors.initials: T
authors.lastname: Beresford
authors.forename: Jan
authors.initials: J
authors.lastname: Campbell
authors.forename: William
authors.initials: W
authors.lastname: Haning
authors.forename: Joseph
authors.initials: J
authors.lastname: Mawhinney
authors.forename: Michael
authors.initials: M
authors.lastname: McCann
authors.forename: Richard
authors.initials: R
authors.lastname: Rawson
authors.forename: Christopher
authors.initials: C
authors.lastname: Stock
authors.forename: Dennis
authors.initials: D
authors.lastname: Weis
authors.forename: Elmer
authors.initials: E
authors.lastname: Yu
authors.forename: Ahmed M
authors.initials: AM
authors.lastname: Elkashef
mesh_terms: D000328:Adult; D019969:Amphetamine-Related Disorders / Q000188:drug therapy* / Q000628:therapy; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008694:Methamphetamine; D000077408:Modafinil; D010352:Patient Dropouts; D011615:Psychotherapy, Group; D016896:Treatment Outcome
chemical_list: D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D008694:Methamphetamine; D000077408:Modafinil