Modafinil vs Placebo for the Treatment of Methamphetamine Dependence
Condition: Methamphetamine Dependence
Intervention: Modafinil; Placebo
Intervention description: 400mg pills taken orally daily for 12 wks.; 400mg pills taken orally daily for 12 wks
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methamphetamine; Modafinil; Medication; Contingency Management; Crystal meth; Los Angeles; Addiction; Meth

Summary:

      Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and
      is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise
      mechanism of action in promoting wakefulness remains unclear. This trial is a
      placebo-controlled double-blind trial of modafinil, on a platform of contingency management
      (CM) and individual cognitive-behavioral (CBT) counseling, for the treatment of
      methamphetamine dependence. Participants in this study will complete a 2-week baseline
      screening period during which they will provide urine samples and complete physical and
      psychological assessments to establish their eligibility for the study. In addition,
      participants will be asked to provide a blood or saliva specimen for genetic testing in order
      to identify genetic variations that influence response to methamphetamine and to treatment
      with modafinil. Upon successful completion of screening, participants will be randomly
      assigned to receive either modafinil (400mg qd) or placebo during the 12 weeks of the study.
      Neither the participants nor study staff will know who is receiving active medication or
      placebo. Regardless of medication condition, all participants will receive CM and weekly
      individual CBT counseling sessions to help them stop using methamphetamine and prevent
      relapse. They will attend the clinical research site (either at the UCLA Hollywood Clinic, or
      the Rancho Cucamonga site) three times per week, providing urine samples at each visit,
      completing data measures, and receiving individual CBT counseling on one visit each week. At
      the end of the 12-week study, the medication or placebo will be discontinued. Participants
      will return to the research site approximately 30 days following medication discontinuation
      for a brief health check to assess any possible lingering side effects and complete brief
      data measures.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older;

          2. meet DSM-IV criteria for methamphetamine dependence;

          3. willing and able to comply with study procedures;

          4. willing and able to provide written informed consent;

          5. if female, not pregnant or lactating and willing to use an acceptable method of
             barrier birth control (e.g. condoms) during the trial and for one month after
             discontinuation of study medication (modafinil may reduce the effectiveness of
             steroidal contraceptives both during administration and for one month after
             discontinuation).

        Exclusion Criteria:

          1. have a medical condition that, in the study physician's judgment, may interfere with
             safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease,
             unstable diabetes, or elevated liver enzymes (SGOT or SGPT) greater than 4 times the
             upper limit of normal);

          2. have a current neurological disorder (e.g., organic brain disease, dementia) or major
             psychiatric disorder not due to substance abuse (e.g., schizophrenia or bipolar
             illness) as assessed by the SCID and a medical history which would make study agent
             compliance difficult or which would compromise informed consent, or recent (past 30
             days) history of suicide attempts and/or current serious suicidal intention or plan as
             assessed by the SCID and the BDI-II;

          3. currently on prescription medication that is known to interact with the study drug;

          4. have current dependence on cocaine, opiates, alcohol, or benzodiazepines, as defined
             by DSM-IV-TR criteria;

          5. have a history of alcohol dependence within the past three years;

          6. have a history of mitral valve prolapse, left ventricular hypertrophy, cardiac
             arrhythmias, angina, myocardial infarction, acute coronary syndrome (unstable angina),
             cardiac syncope or presyncope, or any EKG abnormalities that suggests the presence of
             one of these conditions;

          7. have a systolic blood pressure greater than 160, a diastolic blood pressure greater
             than 100 (i.e. cutoffs for stage 2 hypertension), and a heart rate greater than 70% of
             the maximum heart rate expected for their age (0.70(220-age)) at any of the study
             visits.

          8. any other circumstances that, in the opinion of the investigators, would compromise
             participant safety;

          9. have a history of sensitivity to modafinil.