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

Phase 2

Completed

• Conditions: Schizophrenia; Tobacco Use Cessation; Tobacco Use Disorder
• Interventions: Drug: Bupropion; Drug: nicotine transdermal patch

• Registration Number: NCT00124683
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief 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.

Detailed Description

Past research on the use of the NTP, atypical antipsychotics, and bupropion in schizophrenic individuals to aid in smoking cessation has been encouraging. The purpose of this study is to compare bupropion SR to a placebo to determine its effectiveness when used in combination with an NTP to help schizophrenic individuals quit smoking.

Participants in this double-blind, placebo-controlled study will be randomly assigned to receive either the NTP (21 mg/day) and placebo or the NTP and bupropion SR (300 mg/day). Participants will begin taking one pill each day of bupropion SR (150 mg/day) or placebo at the start of the second week of the study. After three days, the dose of bupropion SR or placebo will increase to 2 pills each day. Participants will continue this dosing regimen until the end of Week 10. Throughout the 10-week study, participants will receive weekly group therapy.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2005-07-26
• Study First Submitted QC: 2005-07-26
• Study First Posted: 2005-07-28
• Study Completion: 2007-05
• Status Verified: 2007-08
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	nicotine transdermal patch	Nicotine Patch + Bupropion
1	Bupropion	Nicotine Patch + Bupropion
2	nicotine transdermal patch	Nicotine patch + placebo

Primary Outcome Measures

Name	Time	Method
7 day point prevalence of cigarette abstinence	End of trial (week 10)

Secondary Outcome Measures

Name	Time	Method
Craving	assessed weekly
Depression	assessed at weeks 1, 4, 7, 10 and at six-month followup
Withdrawal symptoms	assessed weekly and at six month followup
Schizophrenic symptoms	assessed at weeks 1, 4, 7, 10 and at six-month followup
Medication compliance	assessed weekly