Nicotine Replacement Therapy for Smoking Cessation in Schizophrenia
This study has been completed.
Sponsor:
North Suffolk Mental Health Association
Information provided by:
North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00320723
First received: April 28, 2006
Last updated: May 15, 2009
Last verified: May 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder |
Drug: bupropion, transdermal nicotine patch |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Nicotine Replacement Therapy Added to Cognitive Behavioral Therapy for Smoking Cessation in Patients With Major Mental Illness |
Resource links provided by NLM:
Drug Information available for:
Nicotine tartrate
Bupropion hydrochloride
Bupropion
Nicotine polacrilex
U.S. FDA Resources
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 > 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
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
No publications provided
| 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 |
| Study First Received: | April 28, 2006 |
| Last Updated: | May 15, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Smoking Schizophrenia and Disorders with Psychotic Features Mental Disorders Habits Nicotine Nicotine polacrilex Bupropion Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013