Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00136760
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 57
• Location: 1
• Arms: 4
• Duration (Months): 66
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder	Drug: Bupropion; Drug: Contingent reinforcement plus placebo; Drug: non-contingent reinforcement plus bupropion; Drug: Non-contingent reinforcement plus placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Incentives Plus Bupropion for Smoking in Schizophrenics
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Contingent reinforcement plus bupropion	Drug: Bupropion; Contingent reinforcement plus bupropion (300 mg/day for 3 weeks); Other Names: zyban, wellbutrin
Experimental: 2 Contingent reinforcement plus placebo	Drug: Contingent reinforcement plus placebo; contingent reinforcement plus placebo (3 weeks)
Experimental: 3 Non-contingent reinforcement plus bupropion	Drug: non-contingent reinforcement plus bupropion; non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks); Other Names: zyban, wellbutrin
Placebo Comparator: 4 Non-contingent reinforcement plus placebo	Drug: Non-contingent reinforcement plus placebo; Non-contingent reinforcement plus placebo

Outcome Measures

Primary Outcome Measures

1. Urinary Cotinine [3 weeks]

   Urinary Cotinine levels at Week 4 (average of last 3 study visits)

Secondary Outcome Measures

1. Cigarettes Smoked Per Day [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brown University	Providence	Rhode Island	United States	02912

Sponsors and Collaborators

• Brown University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Jennifer W. Tidey, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Tidey, Associate Professor (Research), Dept Psychiatry and Human Behavior, Brown University
• ClinicalTrials.gov Identifier: NCT00136760
• Other Study ID Numbers: NIDA-17566-1; R01DA017566; R01-17566-1
• First Posted: Aug 29, 2005
• Last Update Posted: Oct 7, 2015
• Last Verified: Apr 1, 2013

• Keywords provided by Jennifer Tidey, Associate Professor (Research), Dept Psychiatry and Human Behavior, Brown University: tobacco
• Additional relevant MeSH terms: Disease; Tobacco Use Disorder; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Bupropion

Study Results

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 Detail	Participants underwent telephone and in-person screening for eligibility criteria.

Arm/Group Title	CM + BUP	CM + PLA	NR + BUP	NR + PLA
Arm/Group Description	Contingent reinforcement plus bupropion	Contingent reinforcement plus placebo	Non-contingent reinforcement plus bupropion	Non-contingent reinforcement plus placebo
Period Title: Overall Study
STARTED	12	16	11	13
COMPLETED	12	16	11	13
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	CM + BUP	CM + PLA	NR + BUP	NR + PLA	Total
Arm/Group Description	Contingent reinforcement plus bupropion	Contingent reinforcement plus placebo	Non-contingent reinforcement plus bupropion	Non-contingent reinforcement plus placebo	Total of all reporting groups
Overall Participants	12	16	11	13	52
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	12 75%	10 90.9%	13 100%	47 90.4%
>=65 years	0 0%	4 25%	1 9.1%	0 0%	5 9.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.9 (11.9)	46.3 (6.7)	43.7 (7.3)	46.9 (6.8)	45.1 (8.2)
Sex: Female, Male (Count of Participants)
Female	4 33.3%	6 37.5%	3 27.3%	2 15.4%	15 28.8%
Male	8 66.7%	10 62.5%	8 72.7%	11 84.6%	37 71.2%
Region of Enrollment (participants) [Number]
United States	12 100%	16 100%	11 100%	13 100%	52 100%

Outcome Measures

1. Primary Outcome

Title	Urinary Cotinine
Description	Urinary Cotinine levels at Week 4 (average of last 3 study visits)
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CM + BUP	CM + PLA	NR + BUP	NR + PLA
Arm/Group Description	Contingent reinforcement plus bupropion	Contingent reinforcement plus placebo	Non-contingent reinforcement plus bupropion	Non-contingent reinforcement plus placebo
Measure Participants	12	16	11	13
Mean (Standard Deviation) [ng/ml]	755 (533)	1102 (639)	1534 (489)	1408 (490)

2. Secondary Outcome

Title	Cigarettes Smoked Per Day
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CM + BUP	CM + PLA	NR + BUP	NR + PLA
Arm/Group Description	Contingent reinforcement plus bupropion	Contingent reinforcement plus placebo	Non-contingent reinforcement plus bupropion	Non-contingent reinforcement plus placebo
Measure Participants	12	16	11	13
Mean (Standard Deviation) [cigarettes per day]	12.7 (7.4)	13.9 (9.5)	18.8 (12.9)	21.0 (9.3)

Adverse Events

Arm/Group Title	CM + BUP		CM + PLA		NR + BUP		NR + PLA
Arm/Group Description	Contingent reinforcement plus bupropion		Contingent reinforcement plus placebo		Non-contingent reinforcement plus bupropion		Non-contingent reinforcement plus placebo
All Cause Mortality
	CM + BUP		CM + PLA		NR + BUP		NR + PLA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CM + BUP		CM + PLA		NR + BUP		NR + PLA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/16 (0%)		0/11 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	CM + BUP		CM + PLA		NR + BUP		NR + PLA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/12 (33.3%)		0/16 (0%)		3/11 (27.3%)		2/13 (15.4%)
Cardiac disorders
chest pain	0/12 (0%)	0	0/16 (0%)	0	1/11 (9.1%)	1	0/13 (0%)	0
Gastrointestinal disorders
diarrhea, vomiting	1/12 (8.3%)	1	0/16 (0%)	0	1/11 (9.1%)	1	1/13 (7.7%)	1
bleeding ulcer	0/12 (0%)	0	0/16 (0%)	0	0/11 (0%)	0	1/13 (7.7%)	1
General disorders
fall	1/12 (8.3%)	1	0/16 (0%)	0	0/11 (0%)	0	0/13 (0%)	0
Psychiatric disorders
opiate detoxification	0/12 (0%)	0	0/16 (0%)	0	1/11 (9.1%)	1	0/13 (0%)	0
anxiety, restlessness	1/12 (8.3%)	1	0/16 (0%)	0	0/11 (0%)	0	0/13 (0%)	0
Social circumstances
blackout	1/12 (8.3%)	1	0/16 (0%)	0	0/11 (0%)	0	0/13 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.