A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence.

AIM: 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. PARTICIPANTS AND DESIGN: Eighty methamphetamine-dependent subjects in Sydney, Australia were allocated randomly to...

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Publicado en:Addiction Vol. 104; no. 2; pp. 224 - 234
Autores principales: Shearer J, Darke S, Rodgers C, Slade T, van Beek I, Lewis J, Brady D, McKetin R, Mattick RP, Wodak A
Formato: clinical trial research tables/charts Journal Article
Publicado: Wiley-Blackwell Feb2009
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Feb2009
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        atl: A double-blind, placebo-controlled trial of modafinil (200 mg/day) for methamphetamine dependence.
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          Shearer J
          Darke S
          Rodgers C
          Slade T
          van Beek I
          Lewis J
          Brady D
          McKetin R
          Mattick RP
          Wodak A
        affil: National Drug and Alcohol Research Centre, University of New SouthWales, Sydney, NSW, Australia
      sug:
        subj:
          Modafinil Administration and Dosage
          Modafinil Therapeutic Use
          Substance Dependence Drug Therapy
          Adult
          Analysis of Covariance
          Australia
          Brief Symptom Inventory
          Chi Square Test
          Cognitive Therapy
          Confidence Intervals
          Counseling
          Data Analysis Software
          Descriptive Statistics
          Double-Blind Studies
          Female
          Funding Source
          Immunoassay
          Interview Guides
          Interviews
          Male
          Mann-Whitney U Test
          Methamphetamine
          Middle Age
          Modafinil Adverse Effects
          Pretest-Posttest Design
          Prospective Studies
          Psychological Tests
          Scales
          Self Report
          Severity of Illness Indices
          Mass Spectrometry
          Substance Abuse Detection
          Survival Analysis
          T-Tests
          Treatment Outcomes
          Urinalysis
          Visual Analog Scaling
          Human
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Female
          Male
      ab: AIM: 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. PARTICIPANTS AND DESIGN: 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. MEASURES: 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.
      pubtype: Academic Journal
      doctype:
        clinical trial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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