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Smoking Relapse Prevention in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A. Eden Evins, North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00320697
First received: April 28, 2006
Last updated: September 23, 2016
Last verified: September 2016
  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 + nicotine patch + nicotine gum or lozenges
Drug: Placebo pill + placebo patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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:
  • Effectiveness of 44 weeks extended duration combination treatment with bupropion SR and NRT compared with placebo on 7-day point-prevalence abstinence at the end of the 44-week of the randomized phase [ Time Frame: 7-day point-prevalence abstinence at the end of the 44-week of the randomized phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To establish the safety and tolerability of bupropion SR, 300 mg/day, nicotine patch, 21 mg/day when combined with antipsychotic medications for 12 months in recently abstinent smokers with clinically stable schizophrenia [ Time Frame: thought study completion ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: April 2006
Study Completion Date: August 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bupropion + Nicotine patch + Nicotine gum or lozenges
Open label phase All enrolled subjects received weekly CBT group sessions, bupropion 300 mg/daily (if medically eligible), nicotine patch 21 mg/day, and up to 20 mg/day of nicotine gum or lozenge for prn use. Subjects set a quit date between weeks 3 and 4; a ½ hour individual CBT session to help prepare them for the quit date. The open phase groups consisted of 8 weekly CBT meetings.
Drug: bupropion + nicotine patch + nicotine gum or lozenges
Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.
Active Comparator: Bupropion + Nicotine Patch
Randomized phase: Subjects who achieved 2 weeks continuous abstinence at the end of the open intervention and who are medically eligible for bupropion were eligible for the double blind, relapse prevention trial.Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.
Drug: bupropion + nicotine patch + nicotine gum or lozenges
Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.
Placebo Comparator: Placebo pill + placebo patch
Randomized phase: Subjects who achieved 2 weeks continuous abstinence at the end of the open intervention and who are medically eligible for bupropion were eligible for the double blind, relapse prevention trial. Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.
Drug: Placebo pill + placebo patch
Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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

Responsible Party: A. Eden Evins, Director Center for Addiction Medicine, North Suffolk Mental Health Association
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: September 23, 2016
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
Recurrence
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
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

ClinicalTrials.gov processed this record on September 29, 2016