title: Aripiprazole for the treatment of methamphetamine dependence: a randomized, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo.
  
  
  METHODS
  Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3-month follow-up and a platform of weekly 30-minute substance abuse counseling.
  
  
  METHODS
  The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health.
  
  
  METHODS
  Ninety actively using, methamphetamine-dependent, sexually active adults were recruited from community venues.
  
  
  METHODS
  The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence [by self-report and medication event monitoring systems (MEMS)], sexual risk behavior and abstinence from methamphetamine.
  
  
  RESULTS
  Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African American, and 16.7% Latino. Eighty-three per cent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo [risk ratio (RR) 0.88, 95% confidence interval (CI): 0.66-1.19, P = 0.41]. Urine positivity declined from 73% (33 of 45 participants) to 45% (18 of 40) in the placebo arm and from 77% (34 of 44) to 44% (20 of 35) in the aripiprazole arm. Adherence by MEMS and self-report was 42 and 74%, respectively, with no significant difference between arms (MEMS P = 0.31; self-report P = 0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue and drowsiness (P < 0.05).
  
  
  CONCLUSIONS
  Compared with placebo, aripiprazole did not reduce methamphetamine use significantly among actively using, dependent adults.
authors.affiliation: San Francisco Department of Public Health, San Francisco, California, USA; University of California, San Francisco, CA 94102, USA. pcoffin@gmail.com
authors.forename: Phillip Oliver
authors.initials: PO
authors.lastname: Coffin
authors.forename: Glenn-Milo
authors.initials: GM
authors.lastname: Santos
authors.forename: Moupali
authors.initials: M
authors.lastname: Das
authors.forename: Deirdre M
authors.initials: DM
authors.lastname: Santos
authors.forename: Shannon
authors.initials: S
authors.lastname: Huffaker
authors.forename: Tim
authors.initials: T
authors.lastname: Matheson
authors.forename: James
authors.initials: J
authors.lastname: Gasper
authors.forename: Eric
authors.initials: E
authors.lastname: Vittinghoff
authors.forename: Grant N
authors.initials: GN
authors.lastname: Colfax
mesh_terms: D000328:Adult; D019969:Amphetamine-Related Disorders / Q000534:rehabilitation* / Q000652:urine; D000068180:Aripiprazole; D003131:Combined Modality Therapy; D003376:Counseling; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008694:Methamphetamine; D010879:Piperazines / Q000627:therapeutic use*; D015363:Quinolones / Q000627:therapeutic use*; D015813:Substance Abuse Detection; D017211:Treatment Failure
chemical_list: D018491:Dopamine Agonists; D010879:Piperazines; D015363:Quinolones; D008694:Methamphetamine; D000068180:Aripiprazole