Schizophrenia Clinical Trial
Official title:
Optimizing Treatment for Schizophrenic Smokers
Verified date | August 2007 |
Source | National Institute on Drug Abuse (NIDA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | May 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 7 day point prevalence of cigarette abstinence | End of trial (week 10) | ||
Secondary | Craving | assessed weekly | ||
Secondary | Medication compliance | assessed weekly | ||
Secondary | Depression | assessed at weeks 1, 4, 7, 10 and at six-month followup | ||
Secondary | Withdrawal symptoms | assessed weekly and at six month followup | ||
Secondary | Schizophrenic symptoms | assessed at weeks 1, 4, 7, 10 and at six-month followup |
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