Modafinil for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Intervention: Modafinil; Placebo
Intervention description: 400 mg/day; inactive substance
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10
      week, double bind, placebo controlled, randomized clinical trial to receive either modafinil
      or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential
      facility to achieve initial abstinence and be inducted onto study medication during wks 1-2.
      Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly
      psychotherapy while continuing to receive study medications. Urine samples will be collected
      thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the
      results of this study will contribute to our understanding of which types of agents may be
      good candidates for further development as potential treatment agents for this disorder.
    

Eligibility criteria:

        Inclusion Criteria:

        18-65 years old. For the neurophysiological measures portion of the study subjects will be
        included if they are between the ages of 20-65 because the P50 potential is not fully
        developed in children and adolescents (Rasco 2000).

          -  not currently enrolled in a treatment program

          -  subjects must have a history of methamphetamine use with recent use confirmed by a
             positive urine toxicology screen for amphetamines during the month prior to study
             entry

          -  subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the
             substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)

          -  women of childbearing age must have a negative pregnancy test to enroll in this study,
             agree to monthly pregnancy testing, and agree to use appropriate forms of birth
             control for the duration of the study.

        Exclusion Criteria:

          -  current diagnosis of alcohol, opiate, or sedative physical dependence

          -  ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)

          -  history of schizophrenia, or bipolar type I disorder

          -  present or recent use of over-the-counter or prescription psychoactive drug or drug(s)
             that would be expected to have major interaction with drug to be tested

          -  medical contraindication to receiving study medications (e.g., allergy to modafinil,
             treatment with cyclosporine, clomipramine or desipramine)

          -  current suicidality or psychosis

          -  Liver function tests (i.e., liver enzymes) greater than three times normal levels

          -  pregnancy or breastfeeding