Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Bupropion; Nicotine

Criteria

Inclusion Criteria:

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence

• Fagerstrom Test for Nicotine Dependence (FTND) score greater than 5

• Smokes at least 20 cigarettes per day (1 pack per day)

• Expired breath CO level > 10 ppm and cotinine level > 210 ng/ml at the baseline measurement

• Currently taking a stable dose of antipsychotic

• Complete remission from positive symptoms of psychosis as judged by a psychiatric evaluation

Exclusion Criteria:

• Meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month

• History of hypersensitivity to bupropion or the nicotine transdermal patch (NTP)

• Current diagnosis of a serious documented medical disorder that would make bupropion treatment risky OR results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus)

• Currently taking monoamine oxidase inhibitors or bupropion (Zyban or Wellbutrin)

• Currently taking diabetes mellitus medications, St. John's Wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations)

• History of schizoaffective disorder and not stabilized on a mood stabilizer (e.g., lithium, valproate, carbamazepine)