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Clinical Trials/NCT01214005
NCT01214005CompletedPhase 2

Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls

Brown University1 site in 1 country60 target enrollmentStarted: June 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
urge to smoke

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

schizophrenia

Experimental

Smokers with schizophrenia or schizoaffective disorder

Intervention: smoking abstinence (Behavioral)

non-psychiatric

Other

smokers without psychiatric illness

Intervention: smoking abstinence (Behavioral)

Outcomes

Primary Outcomes

urge to smoke

Time Frame: 3 days

craving for smoking

positive and negative mood

Time Frame: before and after 3 days of abstinence

positive and negative mood scale

Withdrawal symptoms

Time Frame: 3 days

negative mood related to nicotine withdrawal

nicotine preference

Time Frame: before and after 3 days of abstinence

choice for nicotine puffs versus denicotinized cigarette puffs

Secondary Outcomes

  • time to lapse(192 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Tidey

Associate Professor (Research)

Brown University

Study Sites (1)

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