A Comparison of Bupropion SR and Placebo for Smoking Cessation

NCT00176449 | Completed Phase 4 DMC

• 1 other identifier: H-20763
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether the adjunctive use of bupropion SR in the context of a psychoeducational program modified for people with schizophrenia might improve the likelihood of successful abstinence in this population. If bupropion SR is effective for reducing cigarette smoking, then it will be important to determine if decreased nicotine intake is associated with a worsening of psychotic, anxiety or depressive symptoms. In addition, it would be important to determine the effect that a reduction in nicotine stimulation would have on patient's cognitive functioning, as nicotinic receptors have been shown to regulate attention and memory function, and it is hypothesized that these functions are normalized by acute nicotine administration in people with schizophrenia

Conditions

Tobacco Use Disorder

Keywords

Nicotine Dependence; Nicotine Use Disorder; Tobacco Dependence; Tobacco-Use Disorder; Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their

  Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8

• Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function.

  Beginning and end of study

Secondary Outcomes (2)

• BPRS, SANS, EPRS, and body weight will be used to determine the effects of bupropion SR and smoking cessation on patients' positive and negative symptoms, level of functioning, and physical health.

  Baseline, week 2, 4, 8, and 14

• To determine whether responses to the Smoking Consequences Questionnaire, Change Assessment Scale, Temptation to Smoke Scale, Decisional Balance Scale, and Smoking Abstinence Self-Efficacy Scale correlate with successful smoking cessation.

  Beginning and end of study

Study Arms (2)

Bupropion SR

ACTIVE COMPARATOR

Drug: Bupropion SR

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

Bupropion SR DRUG

150mg twice a day (starting with 150mg once a day for three days)

Bupropion SR

Placebo Oral Tablet DRUG

Comparable placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-IV diagnosis of Schizophrenia or schizoaffective disorder
• Age: 18-64
• Regular half pack a day smokers
• Score of at least 4 on the Nicotine Dependency Test

You may not qualify if:

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• Seizure disorders, other Neurologic illnesses, or a family history of seizures
• A medical condition that could manifest psychiatrically
• Currently experiencing a depressive episode
• Active substance abuse
• Currently receiving bupropion
• Pregnant women
• Children (\<18 years of age)
• Two consecutive sodium levels of 130 mmol/L or less

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Maryland Psychiatric REsearch Center

Catonsville, Maryland, 21228, United States

Location

Related Publications (4)

• Weiner E, Ball MP, Summerfelt A, Gold J, Buchanan RW. Effects of sustained-release bupropion and supportive group therapy on cigarette consumption in patients with schizophrenia. Am J Psychiatry. 2001 Apr;158(4):635-7. doi: 10.1176/appi.ajp.158.4.635.

  PMID: 11282701 RESULT

• Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

  PMID: 37230961 DERIVED

• Agarwal SM, Stogios N, Ahsan ZA, Lockwood JT, Duncan MJ, Takeuchi H, Cohn T, Taylor VH, Remington G, Faulkner GEJ, Hahn M. Pharmacological interventions for prevention of weight gain in people with schizophrenia. Cochrane Database Syst Rev. 2022 Oct 3;10(10):CD013337. doi: 10.1002/14651858.CD013337.pub2.

  PMID: 36190739 DERIVED

• Weiner E, Ball MP, Buchholz AS, Gold JM, Evins AE, McMahon RP, Buchanan RW. Bupropion sustained release added to group support for smoking cessation in schizophrenia: a new randomized trial and a meta-analysis. J Clin Psychiatry. 2012 Jan;73(1):95-102. doi: 10.4088/JCP.10m06143gre. Epub 2011 Apr 5.

  PMID: 21535998 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Elaine E Weiner, MD

  University of Maryland, College Park

  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: Chief, Maryland Psychiatric Research Center, Outpatient Research Program

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2001
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

US (1)