Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00307203

Purpose

Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.

Condition	Intervention	Phase
Tobacco-Use Disorder Schizophrenia Psychotic Disorders	Drug: bupropion SR Behavioral: Cognitive Behavioral Group Therapy Drug: nicotine replacement therapy	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Nicotine and Smoking Cessation in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: 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 National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline [ Time Frame: end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report) [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report) [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
psychotic symptoms [ Time Frame: continuous and end of treatment ] [ Designated as safety issue: No ]
negative side effects [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases [ Time Frame: continuous and end of treatment ] [ Designated as safety issue: No ]
measures of attention and memory while attempting to quit smoking [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
health-related quality at the end of the 3-month treatment and 3-month follow-up phases [ Time Frame: continuous and end of treatment ] [ Designated as safety issue: No ]
weight gain at the end of the 3-month treatment and 3-month follow-up phases [ Time Frame: continuous and end of treatment ] [ Designated as safety issue: No ]

Enrollment:	51
Study Start Date:	August 1998
Study Completion Date:	February 2004
Primary Completion Date:	February 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy	Drug: bupropion SR Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks. Behavioral: Cognitive Behavioral Group Therapy Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week. Drug: nicotine replacement therapy Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
II: Placebo Comparator Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy	Behavioral: Cognitive Behavioral Group Therapy Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week. Drug: nicotine replacement therapy Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.

Arms

Assigned Interventions

I: Experimental

Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy

Drug: bupropion SR

Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.

Behavioral: Cognitive Behavioral Group Therapy

Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.

Drug: nicotine replacement therapy

Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.

II: Placebo Comparator

Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy

Behavioral: Cognitive Behavioral Group Therapy

Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.

Drug: nicotine replacement therapy

Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.

Detailed Description:

Schizophrenia affects 1 % of the population. Among individuals with schizophrenia, between 74 and 92 % smoke cigarettes regularly. Heavy smoking represents a significant and neglected public health problem for people with schizophrenia; smoking cessation treatment is often overlooked as part of the psychiatric care for such individuals.

The most effective treatment for smoking cessation described to date is sustained release (SR) bupropion. Past research suggests that SR bupropion may be especially effective in individuals with depressive symptoms, including individuals with schizophrenia. The purpose of this trial is to evaluate the safety and efficacy of SR bupropion, when combined with cognitive behavioral therapy (CBT), in individuals with schizophrenia.

This trial will last 12 weeks. Participants will be randomly assigned to receive SR bupropion or placebo. All participants will receive weekly CBT. Participants will be followed for 3 months following completion of the 12-week treatment session.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
Receiving a stable dose of antipsychotic medication for at least 1 month prior to study entry
Smokes at least 10 cigarettes per day
Wishes to stop smoking
Attended last three scheduled clinic visits, prior to study entry

Exclusion Criteria:

Significant medical or neurologic illness
History of severe head injury with loss of consciousness
Treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry
Taking clozapine at doses greater than 500 mg/d without an anticonvulsant
Currently undergoing an acute exacerbation of psychotic symptoms
Current or history of bulimia or anorexia
Current excessive water intake
Recent history of mania
Known allergy or hypersensitivity to bupropion
Current substance abuse other than tobacco, nicotine replacement treatment, or smokeless tobacco
Currently receiving treatment with bupropion
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307203

Locations

United States, Massachusetts
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

A Eden Evins, MD, MPH

Massachusetts General Hospital

More Information

Publications:

Evins AE, Cather C, Culhane MA, Birnbaum A, Horowitz J, Hsieh E, Freudenreich O, Henderson DC, Schoenfeld DA, Rigotti NA, Goff DC. A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. J Clin Psychopharmacol. 2007 Aug;27(4):380-6.

Responsible Party:	NIDA ( Ivan Montoya )
Study ID Numbers:	K23DA00510, DPMC
Study First Received:	March 23, 2006
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00307203 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Bupropion
Zyban
Wellbutrin
Smoking cessation

Schizophrenia
Schizoaffective disorder
Cognitive Behavioral Therapy

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Nicotine polacrilex
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Cholinergic Agents
Schizophrenia
Pathologic Processes
Nicotine
Mental Disorders

Therapeutic Uses
Ganglionic Stimulants
Substance-Related Disorders
Psychotic Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Schizophrenia and Disorders with Psychotic Features
Disease
Tobacco Use Disorder
Central Nervous System Stimulants
Pharmacologic Actions
Autonomic Agents
Bupropion
Dopamine Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009