Smoking Relapse Prevention in Schizophrenia

NCT00320697 | Completed Phase 4

• 2 other identifiers: CORRC 15-2005HRC#2005-p-001950
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Smokers

Keywords

schizophrenia; smoking cessation; relapse prevention; nicotine; bupropion; cognitive behavioral therapy; nicotine replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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

  7-day point-prevalence abstinence at the end of the 44-week of the randomized phase

Secondary Outcomes (1)

• 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

  thought study completion

Study Arms (3)

Bupropion + Nicotine patch + Nicotine gum or lozenges

OTHER

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

Bupropion + Nicotine Patch

ACTIVE COMPARATOR

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

Placebo pill + placebo patch

PLACEBO COMPARATOR

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

Interventions

bupropion + nicotine patch + nicotine gum or lozenges DRUG

Subjects eligible for bupropion were randomized to receive either nicotine patch and bupropion or placebo patch and pill added to CBT for 44 weeks.

Bupropion + Nicotine Patch; Bupropion + Nicotine patch + Nicotine gum or lozenges

Placebo pill + placebo patch DRUG

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 pill + placebo patch

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Suffolk Mental Health Association: lead

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Smoking Cessation

Interventions

Bupropion; Tobacco Use Cessation Devices; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• A Eden Evins, MD, MPH

  North Suffolk Mental Health Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Center for Addiction Medicine

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: April 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: August 1, 2009
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

US (1)