Status:
COMPLETED
Nicotine Replacement Therapy for Smoking Cessation in Schizophrenia
Lead Sponsor:
North Suffolk Mental Health Association
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This proposal seeks to evaluate a pilot smoking cessation treatment program that will combine nicotine replacement therapy with or without bupropion sustained-release (SR) with cognitive behavioral th...
Detailed Description
Background: Seventy-four to 92% of patients with schizophrenia smoke cigarettes compared to 24% of the adult US population and 18% of adults in Massachusetts (1-3). Patients with schizophrenia also s...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Women and men aged 18-70 with a diagnosis of schizophrenia or schizoaffective disorder (depressed type or bipolar type) by structured diagnostic interview or chart review
- Clinically stable on a stable dose of antipsychotic medication for at least one month, no current active suicidal ideation
- Expired air CO \> 9 ppm and self report of smoking \>1/2 pack per day of cigarettes
- Willing to set a smoking quit date within one month of beginning treatment
- Not treated with investigational medication in the past 30 days
- Competent to provide informed consent or able to provide assent with legal guardian informed consent
- Meet DSM-IV criteria for Nicotine Dependence, as determined with the Fagerstrom Nicotine Tolerance Questionnaire (FTQ) (Fagerstrom, 1978)
- Compliant with last 3 clinic visits
- Exclusion Criteria
- Diagnosis of dementia, neurodegenerative disease, current anorexia/bulimia nervosa, current substance abuse or dependence disorders, including alcohol, active within the last 3 months or any Axis I DSM-IV diagnosis other than schizophrenia or schizoaffective disorder
- Severe or unstable angina; myocardial infarction in the past 2 weeks; untreated peptic ulcer; life-threatening arrhythmia; poorly controlled insulin dependent diabetes mellitus, uncontrolled hypertension, cerebrovascular event within six months; or allergy to a nicotine patch. Serious illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease that is not stabilized such that hospitalization for treatment of that illness is likely within the next two months
- Patients who, in the investigator's opinion, pose a current severe homicide or suicide risk
- Subjects with a history of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings or tapes
- Current use of topical medications
Exclusion
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00320723
Start Date
July 1 2001
End Date
December 1 2005
Last Update
May 19 2009
Active Locations (1)
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1
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114