Nicotine Replacement Therapy for Smoking Cessation in Schizophrenia

NCT00320723 | Completed Phase 4

• 1 other identifier: DMH CORRC 20-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 therapy for smoking cessation in patients with major mental illness.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; smoking cessation; nicotine; patch; bupropion; nicotine replacement therapy; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• improvement in smoking cessation and smoking reduction rates when compared to NRT alone added to CBT in patients with schizophrenia and schizoaffective disorder

Secondary Outcomes (1)

• improvement in negative symptoms, depression and impulsivity when compared to NRT alone in patients with schizophrenia and schizoaffective disorder who quit smoking

Interventions

bupropion, transdermal nicotine patch DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• North Suffolk Mental Health Association: lead

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Smoking Cessation

Interventions

Bupropion; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Therapeutics

Study Officials

• A Eden Evins, MD, MPH

  North Suffolk Mental Health Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: July 1, 2001
• Study Completion: December 1, 2005
• Last Updated: May 19, 2009

Record last verified: 2009-05

Locations

US (1)