title: Double-blind placebo-controlled evaluation of the PROMETA™ protocol for methamphetamine dependence.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the PROMETA™ Protocol for treating methamphetamine dependence.
  
  
  METHODS
  A double-blind, placebo-controlled 108-day study with random assignment to one of two study conditions: active medication with flumazenil (2 mg infusions on days 1, 2, 3, 22, 23), gabapentin (1200 mg to day 40) and hydroxazine (50 mg to day 10) versus placebo medication (with active hydroxazine only).
  
  
  METHODS
  Three substance abuse treatment clinics: two in-patient, one out-patient.
  
  
  METHODS
  Treatment-seeking, methamphetamine-dependent adults (n = 120).
  
  
  METHODS
  Primary outcome was percentage of urine samples testing negative for methamphetamine during the trial.
  
  
  RESULTS
  No statistically significant between-group differences were detected in urine drug test results, craving, treatment retention or adverse events.
  
  
  CONCLUSIONS
  The PROMETA protocol, consisting of flumazenil, gabapentin and hydroxyzine, appears to be no more effective than placebo in reducing methamphetamine use, retaining patients in treatment or reducing methamphetamine craving.
authors.affiliation: University of California, Los Angeles, 90025, USA.
authors.forename: Walter
authors.initials: W
authors.lastname: Ling
authors.forename: Steven
authors.initials: S
authors.lastname: Shoptaw
authors.forename: Maureen
authors.initials: M
authors.lastname: Hillhouse
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Bholat
authors.forename: Charles
authors.initials: C
authors.lastname: Charuvastra
authors.forename: Keith
authors.initials: K
authors.lastname: Heinzerling
authors.forename: David
authors.initials: D
authors.lastname: Chim
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Annon
authors.forename: Patrick T
authors.initials: PT
authors.lastname: Dowling
authors.forename: Geetha
authors.initials: G
authors.lastname: Doraimani
mesh_terms: D000328:Adult; D000588:Amines / Q000008:administration & dosage / Q000009:adverse effects; D019969:Amphetamine-Related Disorders / Q000534:rehabilitation*; D003509:Cyclohexanecarboxylic Acids / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005442:Flumazenil / Q000008:administration & dosage / Q000009:adverse effects; D018757:GABA Modulators / Q000008:administration & dosage* / Q000009:adverse effects; D000077206:Gabapentin; D017442:Histamine Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006919:Hydroxyzine / Q000008:administration & dosage / Q000009:adverse effects; D007262:Infusions, Intravenous; D008297:Male; D055118:Medication Adherence; D008694:Methamphetamine; D057566:Self Report; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D004338:Drug Combinations; D018757:GABA Modulators; D017442:Histamine Agonists; D006919:Hydroxyzine; D005442:Flumazenil; D008694:Methamphetamine; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin
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