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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
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorder focused on measuring nicotine, reinforcement, craving, relapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 1, 2010
Last Updated
April 26, 2012
Sponsor
Brown University
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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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