Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)
Condition: HIV Infections; Depression
MeSH terms: HIV Infections; Depression; Depressive Disorder
Intervention: Bupropion; Placebo
Intervention description: Participants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.; Participants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.
Intervention MeSH terms: Bupropion
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV infection; Depression; Men who have sex with men; Drug abuse

Summary:

      The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons
      with mild-to-moderate depression would be more likely to adopt protective behavior change
      when provided with pharmacotherapy for their depression than when treated with placebo.
      High-risk behaviors include using illegal drugs and participating in unprotected sexual
      intercourse. The specific pharmacotherapy used in this study was the anti-depressant,
      bupropion. The subject population consisted of HIV negative men who have sex with men (MSM)
      with mild-to-moderate depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Available for at least 9 months, or the duration of the study

          -  Willing to complete HIV testing and counseling

          -  History of HIV testing and counseling

          -  At high risk of HIV infection, indicated by more than one male sexual partner in the 3
             months prior to study entry

          -  Meets criteria for either (a) major depression or dysthymia within a mild-to-moderate
             level according to standard criteria DSM-IV, or (b) minor depression as defined by one
             or more of the following symptoms at any time and for any duration during the past 12
             months: significant weight loss or gain, or significant decrease or increase in
             appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of
             energy; inappropriate feelings of worthlessness or guilt; inability to concentrate;
             indecisiveness; and recurrent thoughts of death or suicide.

        Exclusion Criteria:

          -  HIV infected

          -  Sexual intercourse in the 3 months prior to study entry with only one partner, and in
             a monogamous relationship

          -  Currently enrolled in another study involving repeated HIV testing and counseling

          -  Receiving treatment for depression with antidepressant medication for any length of
             time within the year prior to study entry

          -  Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any
             reason

          -  Severe depression or at suicidal risk

          -  No evidence or prior history of depression

          -  Homicidal or other similar problem that, in the opinion of the investigator, may
             endanger study staff and participants

          -  Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed to
             enroll 14 days after discontinuing use of a MAOI.

          -  History of seizures

          -  History or current symptoms of bipolar disorder