Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia
Primary Purpose
Schizophrenia, Tobacco Use Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
300 mg/day bupropion-sr
0 mg/day bupropion-sr
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, tobacco dependence, nicotine
Eligibility Criteria
Inclusion Criteria: Diagnosed with schizophrenia or schizo-affective disorder Smokes between 20 and 50 cigarettes per day Moderate to high nicotine dependence score Interest in quitting smoking Exclusion Criteria: Currently trying to quit smoking Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics Alcohol or drug use disorders Requires certain medications Pregnant or breastfeeding
Sites / Locations
- Providence VA Medical Center, RI
- Brown University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
300 mg/day bupropion-sr
0 mg bupropion-sr
Outcomes
Primary Outcome Measures
Smoking behavior
Secondary Outcome Measures
Adverse events
urge to smoke
nicotine withdrawal symptoms
Full Information
NCT ID
NCT00218231
First Posted
September 16, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00218231
Brief Title
Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia
Official Title
Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.
Detailed Description
There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day).
Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Tobacco Use Disorder
Keywords
schizophrenia, tobacco dependence, nicotine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
300 mg/day bupropion-sr
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
0 mg bupropion-sr
Intervention Type
Drug
Intervention Name(s)
300 mg/day bupropion-sr
Other Intervention Name(s)
zyban, wellbutrin
Intervention Description
300 mg/day for 1 week
Intervention Type
Drug
Intervention Name(s)
0 mg/day bupropion-sr
Other Intervention Name(s)
placebo
Intervention Description
0 mg/day bupropion-sr
Primary Outcome Measure Information:
Title
Smoking behavior
Time Frame
after 5 hrs abstinence
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
ongoing
Title
urge to smoke
Time Frame
after 5 hrs abstinence
Title
nicotine withdrawal symptoms
Time Frame
after 5 hrs withdrawal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed with schizophrenia or schizo-affective disorder
Smokes between 20 and 50 cigarettes per day
Moderate to high nicotine dependence score
Interest in quitting smoking
Exclusion Criteria:
Currently trying to quit smoking
Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics
Alcohol or drug use disorders
Requires certain medications
Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer W. Tidey
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence VA Medical Center, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia
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