Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls

NCT ID: NCT01214005

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-02-29

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.

Conditions

Tobacco Use Disorder; Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

schizophrenia

Smokers with schizophrenia or schizoaffective disorder

Group Type: EXPERIMENTAL

smoking abstinence

Intervention Type: BEHAVIORAL

3 days of biologically-confirmed smoking abstinence

non-psychiatric

smokers without psychiatric illness

Group Type: OTHER

smoking abstinence

Intervention Type: BEHAVIORAL

3 days of biologically-confirmed smoking abstinence

Interventions

smoking abstinence

3 days of biologically-confirmed smoking abstinence

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Tidey

Associate Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Tidey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University, 121 South Main Street

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R21DA026829

Identifier Type: NIH

Identifier Source: org_study_id

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