Nicotine Replacement Therapy for Smoking Cessation in Schizophrenia - Full Text View

Purpose

This proposal seeks to evaluate a pilot smoking cessation treatment program that will combine nicotine replacement therapy with or without bupropion SR with cognitive behavioral therapy for smoking cessation in patients with major mental illness.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: bupropion, transdermal nicotine patch	Phase IV

MedlinePlus related topics:

Mental Health Quitting Smoking Schizophrenia Smoking

Drug Information available for:

Bupropion hydrochloride Bupropion Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Nicotine Replacement Therapy Added to Cognitive Behavioral Therapy for Smoking Cessation in Patients With Major Mental Illness

Further study details as provided by North Suffolk Mental Health Association:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	July 2001
Estimated Study Completion Date:	December 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 > 9ppm 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320723

Locations


United States, Massachusetts
	Freedom Trail Clinic
	Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

North Suffolk Mental Health Association

Investigators


Principal Investigator:	A Eden Evins, MD, MPH	North Suffolk Mental Health Association

More Information

Study ID Numbers:	DMH CORRC 20-01
First Received:	April 28, 2006
Last Updated:	April 28, 2006
ClinicalTrials.gov Identifier:	NCT00320723
Health Authority:	United States: Institutional Review Board

Keywords provided by North Suffolk Mental Health Association:

schizophrenia

smoking cessation

nicotine

patch

bupropion

nicotine replacement therapy

cognitive behavioral therapy

Study placed in the following topic categories:

Nicotine polacrilex

Schizophrenia

Smoking

Dopamine

Nicotine

Mental Disorders

Bupropion

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Cholinergic Agonists

Molecular Mechanisms of Pharmacological Action

Nicotinic Agonists

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Stimulants

Cholinergic Agents

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Ganglionic Stimulants

Dopamine Agents

Peripheral Nervous System Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	North Suffolk Mental Health Association
Information provided by:	North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:	NCT00320723