Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke
Nicotine and Smoking Cessation in Schizophrenia
2 other identifiers
interventional
51
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 1998
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 23, 2006
CompletedFirst Posted
Study publicly available on registry
March 27, 2006
CompletedJanuary 11, 2017
September 1, 2008
5.5 years
March 23, 2006
January 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
end of treatment
Secondary Outcomes (8)
continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)
end of treatment
continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)
end of treatment
psychotic symptoms
continuous and end of treatment
negative side effects
continuous
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
- +3 more secondary outcomes
Study Arms (2)
I
EXPERIMENTALExperiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
II
PLACEBO COMPARATORPlacebo group received placebo, in addition to weekly CBT and nicotine replacement therapy
Interventions
Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Freedom Trail Clinic
Boston, Massachusetts, 02114, United States
Related Publications (2)
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. doi: 10.1097/01.jcp.0b013e3180ca86fa.
PMID: 17632223RESULTHajizadeh 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: 37230961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A Eden Evins, MD, MPH
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 23, 2006
First Posted
March 27, 2006
Study Start
August 1, 1998
Primary Completion
February 1, 2004
Study Completion
February 1, 2004
Last Updated
January 11, 2017
Record last verified: 2008-09