Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls

Schizophrenia Clinical Trial

— WREN  

Official title:

Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214005
• Other study ID #: R21DA026829
• Status: Completed
• Phase: Phase 2
• First received: October 1, 2010
• Last updated: April 26, 2012
• Start date: June 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: National Institutes of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Schizophrenia
• Tobacco Use Disorder

Intervention

Behavioral:
• smoking abstinence
3 days of biologically-confirmed smoking abstinence

Locations

Country	Name	City	State
United States	Brown University, 121 South Main Street	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawal symptoms	negative mood related to nicotine withdrawal	3 days	No
Primary	urge to smoke	craving for smoking	3 days	No
Primary	nicotine preference	choice for nicotine puffs versus denicotinized cigarette puffs	before and after 3 days of abstinence	No
Primary	positive and negative mood	positive and negative mood scale	before and after 3 days of abstinence	No
Secondary	time to lapse	time between smoking behavior in the laboratory and first cigarette outside of the laboratory	192 hours	No