Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls (WREN)
Primary Purpose
Tobacco Use Disorder, Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
smoking abstinence
Sponsored by
About this trial
This is an interventional basic science trial for Tobacco Use Disorder focused on measuring nicotine, reinforcement, craving, relapse
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
Sites / Locations
- Brown University, 121 South Main Street
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
schizophrenia
non-psychiatric
Arm Description
Smokers with schizophrenia or schizoaffective disorder
smokers without psychiatric illness
Outcomes
Primary Outcome Measures
Withdrawal symptoms
negative mood related to nicotine withdrawal
urge to smoke
craving for smoking
nicotine preference
choice for nicotine puffs versus denicotinized cigarette puffs
positive and negative mood
positive and negative mood scale
Secondary Outcome Measures
time to lapse
time between smoking behavior in the laboratory and first cigarette outside of the laboratory
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01214005
Brief Title
Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
Acronym
WREN
Official Title
Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Schizophrenia
Keywords
nicotine, reinforcement, craving, relapse
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
schizophrenia
Arm Type
Experimental
Arm Description
Smokers with schizophrenia or schizoaffective disorder
Arm Title
non-psychiatric
Arm Type
Other
Arm Description
smokers without psychiatric illness
Intervention Type
Behavioral
Intervention Name(s)
smoking abstinence
Intervention Description
3 days of biologically-confirmed smoking abstinence
Primary Outcome Measure Information:
Title
Withdrawal symptoms
Description
negative mood related to nicotine withdrawal
Time Frame
3 days
Title
urge to smoke
Description
craving for smoking
Time Frame
3 days
Title
nicotine preference
Description
choice for nicotine puffs versus denicotinized cigarette puffs
Time Frame
before and after 3 days of abstinence
Title
positive and negative mood
Description
positive and negative mood scale
Time Frame
before and after 3 days of abstinence
Secondary Outcome Measure Information:
Title
time to lapse
Description
time between smoking behavior in the laboratory and first cigarette outside of the laboratory
Time Frame
192 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Tidey, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University, 121 South Main Street
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
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