Trial of Ibudilast for Methamphetamine Dependence
Condition: Methamphetamine Dependence; HIV Infection
MeSH terms: HIV Infections
Intervention: Ibudilast; Placebo
Intervention MeSH terms: Ibudilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: methamphetamine; ibudilast; HIV

Summary:

      The objective of this study is to test the safety and potential efficacy of ibudilast to
      treat methamphetamine dependence. The study hypotheses are that ibudilast will reduce
      methamphetamine use and increase treatment retention more than placebo among patients seeking
      treatment for methamphetamine dependence. As HIV infection is a common complication of
      methamphetamine dependence, half of the participants will be HIV positive and the study will
      assess whether ibudilast also improves HIV related outcomes (e.g. medication adherence, CD4
      count, risk behaviors).
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older;

          2. meet DSM-IV-TR criteria for MA dependence (SCID verified);

          3. a MA-positive urine drug screen at one or more visit during the two week lead-in
             period;

          4. seeking treatment for MA problems;

          5. willing and able to comply with study procedures;

          6. provide written informed consent;

          7. English speaking

          8. reside within 35 miles of the clinical research site; and

          9. if female of childbearing potential, not pregnant or lactating and willing to use a
             medically reliable method of birth control during the trial (e.g., birth control
             pills, Depo-Provera, and/or condoms with spermicide).

        Exclusion Criteria:

          1. 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;
             uncontrolled hypertension; unstable diabetes);

          2. CD4 count < 50 cells/mm3 (suggestive of advanced HIV infection)

          3. AST, ALT, or GGT > 3 times upper normal limit;

          4. A corrected QT of > 450 msecs in men or > 460 msec in women on at least two ECGs
             during the baseline period, or clinical risk factors for Torsades de Pointes (e.g.
             (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or requiring
             ongoing treatment with concomitant medication(s) with established risk of Torsades de
             Pointes (e.g. Amiodarone, Arsenic trioxide, Astemizole, Bepridil, Chloroquine,
             Chlorpromazine, Cisapride, Citalopram, Clarithromycin, Disopyramide, Dofetilide,
             Domperidone, Droperidol, Erythromycin, Flecainide, Halofantrine, Haloperidol,
             Ibutilide, Levomethadyl, Mesoridazine, Methadone, Moxifloxacin, Pentamidine, Pimozide,
             Probucol, Procainamide, Quinidine, Sotalol, Sparfloxacin, Terfenadine, Thioridazine,
             Vandetanib);

          5. current ongoing treatment with psychotropic medications (e.g., antidepressants,
             antipsychotics, antiepileptics, sedative/hypnotics, narcotic analgesics);

          6. a neurological disorder (e.g., organic brain disease, dementia) or a medical condition
             which would make study agent compliance difficult or which would compromise informed
             consent;

          7. a major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar
             disorder) as assessed by the SCID;

          8. attempted suicide in the past 3 years and/or serious suicidal intention or plan in the
             past year as assessed by the C-SSRS;

          9. currently on prescription medication that is contraindicated for use with IBUD
             including alpha or beta agonists, theophylline, or other sympathomimetics;

         10. current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by
             DSM-IV-TR;

         11. alcohol dependence within the past year;

         12. greater than one urine specimens during the lead-in with a riboflavin concentration of
             < 900 ng/ml as assessed via UV fluorescence;

         13. a history of sensitivity to IBUD; or

         14. any other circumstances that, in the opinion of the investigators, would compromise
             participant safety;

         15. current participation in another clinical trial.