A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this pilot study is to determine the safety and potential efficacy of
      sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients
      with bipolar affective illness. It is hypothesized that bupropion will produce a significant
      enhancement of smoking abstinence compared to placebo and will be safe for use in these
      patients.
    

Detailed description: 
      The purpose of this pilot study is to determine the safety and potential efficacy of
      sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients
      with bipolar affective illness. we propose to conduct a preliminary study of the safety and
      efficacy of bupropion SR (with flexible dosing up to 300 mg/day) in comparison to placebo in
      medication-maintained and stabilized outpatients with bipolar I and II disorder who are
      currently depressed despite mood-stabilizing medication and who are also nicotine-dependent
      cigarette smokers, and who are motivated to quit smoking. Subjects will be n=32 subjects
      between 18 and 65 years of age who meet DSM-IV criteria for bipolar disorder (either Type I
      or II), and nicotine dependence, and smoke at least 15 cigarettes per day, with an FTND score
      at baseline >5, expired breath CO >10, and plasma cotinine >150 ng/ml, and are motivated to
      quit smoking within thirty days of the initial intake. Subjects must be on a stable dose of a
      mood stabilizer (e.g. lithium, valproate, carbamezepine, topiramate, gabapentin or atypical
      antipsychotic), and be in complete remission from active manic or hypomanic and psychotic
      symptoms as judged by a psychiatric evaluation. Subjects will be recruited through outpatient
      departments at Connecticut Mental Health Center (CMHC) and its satellite clinics. Study
      medications will be given for 9 weeks duration, beginning at 1 week prior to the "quit date".
      Bupropion [as the intermediate-release (IR) formulation] will begin at 75 mg po qd x 3days,
      then increase to 150 mg [as bupropion SR formulation] qd x 4 days, and then increased to a
      final dose of up to 150 mg po bid (300 mg/day) by Day 15 (the target quit date; TQD) as
      tolerated, and this dose will be continued for an additional eight (8) weeks at up to 150 mg
      po bid. We will allow flexible dosing above 150 mg/day to allow for adjustments needed if a
      bipolar subject does not tolerate the full dose of Zyban at 300 mg/day. Zyban will then be
      discontinued at the end of Week 10. Primary outcome measures are endpoint (7-day) smoking
      abstinence and adverse events.
    

Intervention name(s): Bupropion; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BUP [as the intermediate-release (IR) formulation] was inducted on Day 1 of the trial at 75 mg po qd x 3 days, then increased to 150 mg [as BUP SR formulation] qd x 4 days, and then increased to a final dose of up to 150 mg po bid (300 mg/day) by Day 15 (target quit date; TQD) as tolerated. This dose was continued for an additional eight (8) weeks at up to 150 mg po bid. Flexible dosing was permitted to allow for adjustments needed if a bipolar subject did not tolerate the full dose of BUP at 300 mg/day. BUP was discontinued at the end of Week 10.; matching placebo capsules (PLA) containing only a dextrose matrix.
Other intervention name(s): Zyban
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Nicotine Dependence; Smoking Cessation; Bupropion, sustained-release