Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

• ClinicalTrials.gov Identifier: NCT00136760
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Results First Posted: December 17, 2012
• Last Update Posted: October 7, 2015
• Sponsor: Brown University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Jennifer Tidey, Brown University

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 (Clinical Trial)
• 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: September 2003
• Actual Primary Completion Date: March 2009
• Actual Study Completion Date: March 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 Name: 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 Name: 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 [ Time Frame: 3 weeks ]
   Urinary Cotinine levels at Week 4 (average of last 3 study visits)

Secondary Outcome Measures :

1. Cigarettes Smoked Per Day [ Time Frame: 3 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

United States, Rhode Island

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

More Information

Publications of Results:

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.

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:S54-60. doi: 10.1016/j.ypmed.2011.11.010. Epub 2011 Dec 9. Review.

• 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 ( U.S. NIH Grant/Contract ); R01-17566-1
• First Posted: August 29, 2005
• Results First Posted: December 17, 2012
• Last Update Posted: October 7, 2015
• Last Verified: April 2013

Keywords provided by Jennifer Tidey, Brown University:

tobacco

Additional relevant MeSH terms:

Disease; Tobacco Use Disorder; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Pathologic Processes; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Bupropion; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors