Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder
Conditions
Keywords
tobacco
Brief summary
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.
Detailed description
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.
Interventions
DRUGBupropion
Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
DRUGContingent reinforcement plus placebo
contingent reinforcement plus placebo (3 weeks)
DRUGnon-contingent reinforcement plus bupropion
non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
DRUGNon-contingent reinforcement plus placebo
Non-contingent reinforcement plus placebo
Sponsors
National Institute on Drug Abuse (NIDA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications
Exclusion criteria
Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Cotinine | 3 weeks | Urinary Cotinine levels at Week 4 (average of last 3 study visits) |
Secondary
| Measure | Time frame |
|---|---|
| Cigarettes Smoked Per Day | 3 weeks |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the community, using advertisements, and were recruited from an outpatient clinic at a local VA medical Center.
Pre-assignment details
Participants underwent telephone and in-person screening for eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| CM + BUP Contingent reinforcement plus bupropion | 12 |
| CM + PLA Contingent reinforcement plus placebo | 16 |
| NR + BUP Non-contingent reinforcement plus bupropion | 11 |
| NR + PLA Non-contingent reinforcement plus placebo | 13 |
| Total | 52 |
Baseline characteristics
| Characteristic | CM + PLA | NR + BUP | CM + BUP | NR + PLA | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 10 Participants | 12 Participants | 13 Participants | 47 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 6.7 | 43.7 years STANDARD_DEVIATION 7.3 | 42.9 years STANDARD_DEVIATION 11.9 | 46.9 years STANDARD_DEVIATION 6.8 | 45.1 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 16 participants | 11 participants | 12 participants | 13 participants | 52 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 4 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 8 Participants | 11 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 12 | 0 / 16 | 3 / 11 | 2 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 16 | 0 / 11 | 0 / 13 |
Outcome results
Primary
Urinary Cotinine
Urinary Cotinine levels at Week 4 (average of last 3 study visits)
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CM + BUP | Urinary Cotinine | 755 ng/ml | Standard Deviation 533 |
| CM + PLA | Urinary Cotinine | 1102 ng/ml | Standard Deviation 639 |
| NR + BUP | Urinary Cotinine | 1534 ng/ml | Standard Deviation 489 |
| NR + PLA | Urinary Cotinine | 1408 ng/ml | Standard Deviation 490 |
Secondary
Cigarettes Smoked Per Day
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CM + BUP | Cigarettes Smoked Per Day | 12.7 cigarettes per day | Standard Deviation 7.4 |
| CM + PLA | Cigarettes Smoked Per Day | 13.9 cigarettes per day | Standard Deviation 9.5 |
| NR + BUP | Cigarettes Smoked Per Day | 18.8 cigarettes per day | Standard Deviation 12.9 |
| NR + PLA | Cigarettes Smoked Per Day | 21.0 cigarettes per day | Standard Deviation 9.3 |