Aripiprazole Treatment for Methamphetamine Dependence Among High-risk Individuals
Condition: Substance Abuse; HIV Infections
MeSH terms: Substance-Related Disorders
Intervention: Aripiprazole; Placebo
Intervention description: Sugar pill manufactured to mimic Aripiprazole gel caps.
Intervention MeSH terms: Aripiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Methamphetamine; HIV; MSM; HIV Seronegativity

Summary:

      Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual
      behavior among men who have sex with men (MSM), putting meth-using MSM at extraordinarily
      high risk for transmitting or acquiring HIV. This study is a randomized, double-blind,
      placebo-controlled trial of the medication aripiprazole for methamphetamine-using
      individuals, including MSM, and will assess efficacy, acceptability, tolerability, safety,
      and adherence to study medication.
    

Eligibility criteria:

        A total of 90 high-risk individuals with methamphetamine dependence will be enrolled in the
        study. Subjects will be San Francisco Bay Area residents between 18-60 years of age and in
        good health. The project is designed specifically for those at high risk for HIV
        transmission or acquisition.

        Inclusion Criteria:

          1. HIV-negative by rapid test, or documentation of HIV infection with a laboratory result
             of a positive HIV test;

          2. diagnosed with methamphetamine dependence as determined by SCID;

          3. interested in stopping or reducing methamphetamine use;

          4. at least one methamphetamine-positive urine during screening and run-in period;

          5. no current acute illnesses requiring prolonged medical care;

          6. no chronic illnesses that are likely to progress clinically during trial
             participation;

          7. able and willing to provide informed consent and to be followed over trial period;

          8. age 18-60 years;

          9. baseline CBC, total protein, albumin, glucose, lipid panel, alk phos, creatinine, BUN,
             and electrolytes without clinically significant abnormalities as determined by
             investigator in conjunction with symptoms, physical exam, and medical history.

         10. if sex assigned at birth was female and able to become pregnant: agrees to use birth
             control by any of the following methods - hormonal patch, pills, or injections; IUD;
             diaphragm; condoms; or abstinence.

        Exclusion Criteria:

          1. has a psychiatric disorder as assessed by SCID that in the opinion of evaluating
             clinician would make the study participation unsafe, or make adherence to study
             protocol untenable. Conditions include current major depression, current suicidal
             ideation, bipolar disorder, dementia, or acute psychosis;

          2. taking psychotropic medication within the last 30 days, including aripiprazole;

          3. known allergy to aripiprazole, or known adverse reaction to antipsychotics;

          4. currently using or unwilling not to use phenylephrine or ephedrine-containing products
             for trial duration (can cause false positive urines for methamphetamine use);

          5. current CD4 count < 200 cells/mm3;

          6. using other medications known to interact with aripiprazole, including ketoconazole
             and carbamazepine;

          7. measured moderate or severe liver disease (AST, ALT, and total bilirubin > 3 times
             normal) and/or any symptoms of current liver disease;

          8. impaired renal function (creatinine clearance < 60 ml/min);

          9. diabetes mellitis type I or type II, including cases controlled with diet alone;

         10. Hypertension that is not well-controlled;

         11. BMI ≥ 40; or BMI ≥ 35 with more than one of the following: age > 45, systolic blood
             pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, known hyperlipidemia;

         12. History of, or known active cardiovascular disease including: (a) Previous myocardial
             infarction (heart attack); (b) angina pectoris; (c) congestive heart failure; (d)
             valvular heart disease including mitral valve prolapse; (e) cardiomyopathy; (f)
             pericarditis; (g) stroke or transient ischemic attack; (h) chest pain or shortness of
             breath with activity (such as walking up stairs); (i) peripheral vascular disease or
             risk equivalent; (j) other heart conditions under the care of a doctor;

         13. currently participating in another research study;

         14. pregnant, breast-feeding, and/or positive pregnancy test at screening or enrollment
             visit;

         15. any condition that, in the principal investigator's judgment, interferes with safe
             study participation or adherence to study procedures.