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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA017566 | U.S. NIH Grant/Contract | View source | |
| R01-17566-1 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Contingent reinforcement plus bupropion |
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| 2 | Experimental | Contingent reinforcement plus placebo |
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| 3 | Experimental | Non-contingent reinforcement plus bupropion |
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| 4 | Placebo Comparator | Non-contingent reinforcement plus placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion | Drug | Contingent reinforcement plus bupropion (300 mg/day for 3 weeks) |
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| Measure | Description | Time Frame |
|---|---|---|
| Urinary Cotinine | Urinary Cotinine levels at Week 4 (average of last 3 study visits) | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes Smoked Per Day | 3 weeks |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer W. Tidey | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21475970 | Result | Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM, Reid N. Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia. Psychopharmacology (Berl). 2011 Sep;217(2):279-87. doi: 10.1007/s00213-011-2282-8. Epub 2011 Apr 8. | |
| 22197799 | Result | Tidey JW. Using incentives to reduce substance use and other health risk behaviors among people with serious mental illness. Prev Med. 2012 Nov;55 Suppl(Suppl):S54-60. doi: 10.1016/j.ypmed.2011.11.010. Epub 2011 Dec 9. |
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Participants underwent telephone and in-person screening for eligibility criteria.
Participants were recruited from the community, using advertisements, and were recruited from an outpatient clinic at a local VA medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | CM + BUP | Contingent reinforcement plus bupropion |
| FG001 | CM + PLA | Contingent reinforcement plus placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Contingent reinforcement plus placebo | Drug | contingent reinforcement plus placebo (3 weeks) |
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| non-contingent reinforcement plus bupropion | Drug | non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks) |
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| Non-contingent reinforcement plus placebo | Drug | Non-contingent reinforcement plus placebo |
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| FG002 |
| NR + BUP |
Non-contingent reinforcement plus bupropion |
| FG003 | NR + PLA | Non-contingent reinforcement plus placebo |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CM + BUP | Contingent reinforcement plus bupropion |
| BG001 | CM + PLA | Contingent reinforcement plus placebo |
| BG002 | NR + BUP | Non-contingent reinforcement plus bupropion |
| BG003 | NR + PLA | Non-contingent reinforcement plus placebo |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Cotinine | Urinary Cotinine levels at Week 4 (average of last 3 study visits) | Posted | Mean | Standard Deviation | ng/ml | 3 weeks |
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| Secondary | Cigarettes Smoked Per Day | Posted | Mean | Standard Deviation | cigarettes per day | 3 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CM + BUP | Contingent reinforcement plus bupropion | 0 | 12 | 4 | 12 | ||
| EG001 | CM + PLA | Contingent reinforcement plus placebo | 0 | 16 | 0 | 16 | ||
| EG002 | NR + BUP | Non-contingent reinforcement plus bupropion | 0 | 11 | 3 | 11 | ||
| EG003 | NR + PLA | Non-contingent reinforcement plus placebo | 0 | 13 | 2 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| opiate detoxification | Psychiatric disorders | Systematic Assessment | self-report |
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| diarrhea, vomiting | Gastrointestinal disorders | Systematic Assessment | self-report |
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| fall | General disorders | Systematic Assessment |
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| blackout | Social circumstances | Systematic Assessment | self-report, not related |
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| anxiety, restlessness | Psychiatric disorders | Systematic Assessment | self-report, not related |
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| bleeding ulcer | Gastrointestinal disorders | Systematic Assessment | self-report, not related |
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| chest pain | Cardiac disorders | Systematic Assessment | self-report |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Tidey, Ph.D. | Brown University | 401-863-6418 | Jennifer_Tidey@brown.edu |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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