Smoking Relapse Prevention in Schizophrenia

This study has been completed.
Sponsor:
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
  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:


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:

  1. Women and men aged 18-70 with DSM-IV diagnosis of schizophrenia or schizoaffective disorder by diagnostic interview and 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 > 10ppm and self report of smoking >9 cigarettes per day.
  4. Willing to set a smoking quit date within 3 weeks 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 accompanying informed consent from legal guardian.
  7. Meets DSM-IV criteria for Nicotine Dependence.
  8. 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

  1. 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.)
  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 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. History of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.
  6. Treatment with doses of Clozapine> 500 mg per day without anticonvulsants.
  7. Treatment with monoamine oxidase inhibitors.
  8. Plan to continue to use tobacco products other than cigarettes.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Schizophrenia
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Nicotine
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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014