Effects of Modafinil in Methamphetamine Dependence
Condition: Methamphetamine Dependence
Intervention: Modafinil; Placebo
Intervention description: 400 mg daily for four weeks; Placebo 2 tablets daily for 4 weeks
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Methamphetamine; Modafinil; Addiction; Craving; Cognitive

Summary:

      Methamphetamine dependence is a serious public health problem with no pharmacologic
      treatments currently available. Relapse rates are high in this population. Exposure to cues
      previously associated with methamphetamine use may induce profound craving in abstinent
      individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits
      that may undermine successful participation in psychosocial treatments. Medications which
      improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence
      rates, especially in the critical early period of recovery. Modafinil is an atypical
      stimulant medication with evidence to support its use in treating cocaine dependence and
      attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate
      modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be able to provide informed consent and function at an intellectual
             level sufficient to allow accurate completion of all assessment instruments.

          2. Subjects must meet DSM-IV criteria for methamphetamine dependence within the past six
             months. Subjects may meet criteria for abuse, but not dependence on any other
             substance with the exception of nicotine. Because of the high comorbidity of
             methamphetamine and nicotine dependence, excluding nicotine dependence would seriously
             compromise the feasibility of recruitment. Nicotine use immediately prior to the cue
             reactivity testing session will be controlled.

          3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine)
             for 24 hours prior to the cue reactivity testing sessions.

          4. Subjects must consent to random assignment to the modafinil vs. placebo conditions.

        Exclusion Criteria:

          1. Women who are pregnant, nursing or of childbearing potential and not practicing an
             effective means of birth control.

          2. Subjects with evidence of or a history of significant hematological, endocrine,
             cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these
             conditions may affect heart rate or skin conductance measurement.

          3. Subjects with a history of or current psychotic disorder or bipolar affective disorder
             as these may impact cue reactivity.

          4. Subjects who are unwilling or unable to maintain abstinence from alcohol and other
             drugs of abuse (except nicotine) for 24 hours prior the cue procedures.

          5. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or
             methamphetamine as appropriate) within the past 60 days.

          6. Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any
             other agents known to interfere with heart rate and skin conductance monitoring.

          7. Known or suspected hypersensitivity to modafinil.

          8. Individuals taking medications that could adversely interact with study medications.

          9. Subjects with a history of epilepsy or seizure disorder.