Nicotine Replacement Therapy for Smoking Cessation in Schizophrenia

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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 therapy for smoking cessation in patients with major mental illness.

Key facts

Study ID

NCT00320723

Run by

North Suffolk Mental Health Association

People needed

100

Starts

2001-07-01

Expected to finish

2005-12-01

Last updated by the study team

2009-05-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Freedom Trail Clinic — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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