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

Primary Purpose

Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bupropion
nicotine transdermal patch
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Cessation focused on measuring nicotine dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Nicotine Patch + Bupropion

    Nicotine patch + placebo

    Outcomes

    Primary Outcome Measures

    7 day point prevalence of cigarette abstinence

    Secondary Outcome Measures

    Craving
    Medication compliance
    Depression
    Withdrawal symptoms
    Schizophrenic symptoms

    Full Information

    First Posted
    July 26, 2005
    Last Updated
    January 11, 2017
    Sponsor
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00124683
    Brief Title
    Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1
    Official Title
    Optimizing Treatment for Schizophrenic Smokers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia
    Keywords
    nicotine dependence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    59 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Nicotine Patch + Bupropion
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Nicotine patch + placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Bupropion
    Intervention Type
    Drug
    Intervention Name(s)
    nicotine transdermal patch
    Primary Outcome Measure Information:
    Title
    7 day point prevalence of cigarette abstinence
    Time Frame
    End of trial (week 10)
    Secondary Outcome Measure Information:
    Title
    Craving
    Time Frame
    assessed weekly
    Title
    Medication compliance
    Time Frame
    assessed weekly
    Title
    Depression
    Time Frame
    assessed at weeks 1, 4, 7, 10 and at six-month followup
    Title
    Withdrawal symptoms
    Time Frame
    assessed weekly and at six month followup
    Title
    Schizophrenic symptoms
    Time Frame
    assessed at weeks 1, 4, 7, 10 and at six-month followup

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tony P George, M.D.
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18096137
    Citation
    George TP, Vessicchio JC, Sacco KA, Weinberger AH, Dudas MM, Allen TM, Creeden CL, Potenza MN, Feingold A, Jatlow PI. A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia. Biol Psychiatry. 2008 Jun 1;63(11):1092-6. doi: 10.1016/j.biopsych.2007.11.002. Epub 2007 Dec 21.
    Results Reference
    derived

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

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