Smoking Relapse Prevention in Schizophrenia
This study has been completed.
Sponsor:
North Suffolk Mental Health Association
Information provided by:
North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00320697
First received: April 28, 2006
Last updated: May 15, 2009
Last verified: May 2009
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Purpose
This study seeks to determine if continued treatment with bupropion and nicotine replacement therapy (NRT) can reduce the smoking relapse rate in patients with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Smokers |
Drug: bupropion Drug: transdermal nicotine patch Drug: short-acting nicotine replacement therapy |
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: | A Trial of the Effects of Bupropion, Nicotine Replacement Therapy and CBT on Smoking Cessation and Smoking Relapse in Patients With Schizophrenia |
Resource links provided by NLM:
MedlinePlus related topics:
Mental Disorders
Psychotic Disorders
Quitting Smoking
Schizophrenia
Smoking
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:
- Primary Aim: the effectiveness of 44 weeks extended duration combination treatment with bupropion SR and NRT compared with placebo for prevention of relapse to smoking in patients with schizophrenia
Secondary Outcome Measures:
- Secondary Aims and Exploratory Comparisons: Attention, memory, negative affect, craving and reward responsivity as well as psychosis, depression, anxiety, agitation, and negative symptoms are secondary outcomes and potential mediators of the relationship
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2006 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Women and men aged 18-70 with DSM-IV diagnosis of schizophrenia or schizoaffective disorder by diagnostic interview and chart review.
- Clinically stable on a stable dose of antipsychotic medication for at least one month, no current active suicidal ideation.
- Expired air CO > 10ppm and self report of smoking >9 cigarettes per day.
- Willing to set a smoking quit date within 3 weeks of beginning treatment.
- Not treated with investigational medication in the past 30 days.
- Competent to provide informed consent or able to provide assent accompanying informed consent from legal guardian.
- Meets DSM-IV criteria for Nicotine Dependence.
- Women of childbearing age must have a negative pregnancy test at screening and agree to use an approved form of contraception throughout the study.
Exclusion Criteria
- Diagnosis of dementia, neurodegenerative disease, seizure disorder, 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. (*Note: Subjects with a seizure disorder who would not be medically eligible for bupropion may be allowed to participate, but will not be prescribed bupropion or randomized; rather, they will continue to receive open treatment through the relapse prevention phase.)
- 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 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.
- History of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.
- Treatment with doses of Clozapine> 500 mg per day without anticonvulsants.
- Treatment with monoamine oxidase inhibitors.
- Plan to continue to use tobacco products other than cigarettes.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320697
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: | NCT00320697 History of Changes |
| Other Study ID Numbers: | CORRC 15-2005, HRC#2005-p-001950 |
| 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 relapse prevention nicotine |
bupropion cognitive behavioral therapy nicotine replacement 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 23, 2013