Status:
COMPLETED
Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Cessation
Tobacco Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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 bupro...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00124683
Start Date
September 1 2001
End Date
May 1 2007
Last Update
January 12 2017
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