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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00593099 |
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.
Condition | Intervention | Phase |
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Bipolar Disorder |
Drug: Bupropion Drug: Placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder |
Enrollment: | 5 |
Study Start Date: | April 2004 |
Study Completion Date: | June 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Buproprion
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Drug: Bupropion
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.
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2: Placebo Comparator
Placebo
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Drug: Placebo
matching placebo capsules (PLA) containing only a dextrose matrix.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Connecticut Mental Health Center | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Tony P. George, M.D., FRCPC | University of Toronto |
Responsible Party: | University of Toronto ( Tony P. George, M.D., FRPCP ) |
Study ID Numbers: | 26254 |
Study First Received: | December 28, 2007 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00593099 |
Health Authority: | United States: Federal Government |
Bipolar Disorder Nicotine Dependence Smoking Cessation Bupropion, sustained-release |
Nicotine polacrilex Smoking Affective Disorders, Psychotic Dopamine Nicotine |
Mental Disorders Bipolar Disorder Bupropion Mood Disorders Psychotic Disorders |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |