Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls

Phase 2

Completed

• Conditions: Schizophrenia; Tobacco Use Disorder
• Interventions: Behavioral: smoking abstinence

• Registration Number: NCT01214005
• Lead Sponsor: Brown University

Brief Summary

This project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. The second hypothesis is that smokers with schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more rewarding effects of smoking after a period of abstinence) than control smokers without psychiatric illness.

Detailed Description

In this study, smokers with schizophrenia and smokers without psychiatric illness participate in a nicotine preference task before and after a 3-day period of continuous smoking abstinence. The investigators will experimentally control abstinence by providing participants with high-value cash incentives contingent upon smoking abstinence verified with breath carbon monoxide levels. The investigators will measure nicotine withdrawal and smoking urge during the abstinence period. In the nicotine preference task, participants will make choices between nicotine-containing and denicotinized cigarette puffs to provide a measure of nicotine reinforcement, and the investigators will also measure the effects of smoking on mood. After the second nicotine preference task, participants will receive a small-value reinforcer if they continue to abstain for another day, and the investigators will measure time to the second lapse.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• cigarette smokers, 20-50 cigarettes per day
• schizophrenia or no psychiatric illness
• age 18 or older
• male or female

Exclusion Criteria

• unstable symptoms or medication
• not interested in quitting smoking within 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
schizophrenia	smoking abstinence	Smokers with schizophrenia or schizoaffective disorder
non-psychiatric	smoking abstinence	smokers without psychiatric illness

Primary Outcome Measures

Name	Time	Method
Withdrawal symptoms	3 days	negative mood related to nicotine withdrawal
urge to smoke	3 days	craving for smoking
positive and negative mood	before and after 3 days of abstinence	positive and negative mood scale
nicotine preference	before and after 3 days of abstinence	choice for nicotine puffs versus denicotinized cigarette puffs

Secondary Outcome Measures

Name	Time	Method
time to lapse	192 hours	time between smoking behavior in the laboratory and first cigarette outside of the laboratory

Trial Locations

Locations (1)

Brown University, 121 South Main Street; 🇺🇸 Providence, Rhode Island, United States