Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

Tobacco Use Disorder Clinical Trial

Official title:

Incentives Plus Bupropion for Smoking in Schizophrenics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136760
• Other study ID #: NIDA-17566-1
• Secondary ID: R01DA017566R01-1
• Status: Completed
• Phase: Phase 2
• First received: August 25, 2005
• Last updated: October 5, 2015
• Start date: September 2003
• Est. completion date: March 2009

Study information

• Verified date: April 2013
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Schizophrenia
• Schizophrenia and Disorders with Psychotic Features
• Tobacco Use Disorder

Intervention

Drug:
• Bupropion
Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
• Contingent reinforcement plus placebo
contingent reinforcement plus placebo (3 weeks)
• non-contingent reinforcement plus bupropion
non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
• Non-contingent reinforcement plus placebo
Non-contingent reinforcement plus placebo

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Cotinine	Urinary Cotinine levels at Week 4 (average of last 3 study visits)	3 weeks	No
Secondary	Cigarettes Smoked Per Day		3 weeks	No