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Nicotine Replacement Therapy for Smoking Cessation in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00320723
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : May 19, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: bupropion, transdermal nicotine patch Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Nicotine Replacement Therapy Added to Cognitive Behavioral Therapy for Smoking Cessation in Patients With Major Mental Illness
Study Start Date : July 2001
Estimated Study Completion Date : December 2005

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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
  2. Clinically stable on a stable dose of antipsychotic medication for at least one month, no current active suicidal ideation
  3. Expired air CO > 9 ppm and self report of smoking >1/2 pack per day of cigarettes
  4. Willing to set a smoking quit date within one month of beginning treatment
  5. Not treated with investigational medication in the past 30 days
  6. Competent to provide informed consent or able to provide assent with legal guardian informed consent
  7. Meet DSM-IV criteria for Nicotine Dependence, as determined with the Fagerstrom Nicotine Tolerance Questionnaire (FTQ) (Fagerstrom, 1978)
  8. Compliant with last 3 clinic visits

Exclusion Criteria

  1. 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
  2. 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
  3. Patients who, in the investigator's opinion, pose a current severe homicide or suicide risk
  4. Subjects with a history of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings or tapes
  5. Current use of topical medications
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: A Eden Evins, MD, MPH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00320723     History of Changes
Other Study ID Numbers: DMH CORRC 20-01
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: May 19, 2009
Last Verified: May 2009

Keywords provided by North Suffolk Mental Health Association:
schizophrenia
smoking cessation
nicotine
patch
bupropion
nicotine replacement therapy
cognitive behavioral therapy

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors