Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke

Schizophrenia Clinical Trial

Official title:

Nicotine and Smoking Cessation in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307203
• Other study ID #: K23DA000510
• Secondary ID: DPMC
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2006
• Last updated: January 10, 2017
• Start date: August 1998
• Est. completion date: February 2004

Study information

• Verified date: September 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Tobacco Use Disorder
• Tobacco-Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Freedom Trail Clinic	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 sm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline		end of treatment	No
Secondary	continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)		end of treatment	No
Secondary	continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)		end of treatment	No
Secondary	psychotic symptoms		continuous and end of treatment	No
Secondary	negative side effects		continuous	Yes
Secondary	negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases		continuous and end of treatment	No
Secondary	measures of attention and memory while attempting to quit smoking		end of treatment	No
Secondary	health-related quality at the end of the 3-month treatment and 3-month follow-up phases		continuous and end of treatment	No
Secondary	weight gain at the end of the 3-month treatment and 3-month follow-up phases		continuous and end of treatment	No