Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
WREN
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 1, 2010
CompletedFirst Posted
Study publicly available on registry
October 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedApril 27, 2012
April 1, 2012
2.7 years
October 1, 2010
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Withdrawal symptoms
negative mood related to nicotine withdrawal
3 days
urge to smoke
craving for smoking
3 days
nicotine preference
choice for nicotine puffs versus denicotinized cigarette puffs
before and after 3 days of abstinence
positive and negative mood
positive and negative mood scale
before and after 3 days of abstinence
Secondary Outcomes (1)
time to lapse
192 hours
Study Arms (2)
schizophrenia
EXPERIMENTALSmokers with schizophrenia or schizoaffective disorder
non-psychiatric
OTHERsmokers without psychiatric illness
Interventions
3 days of biologically-confirmed smoking abstinence
Eligibility Criteria
You may qualify if:
- cigarette smokers, 20-50 cigarettes per day
- schizophrenia or no psychiatric illness
- age 18 or older
- male or female
You may not qualify if:
- unstable symptoms or medication
- not interested in quitting smoking within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
Study Sites (1)
Brown University, 121 South Main Street
Providence, Rhode Island, 02912, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Tidey, Ph.D.
Brown University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor (Research)
Study Record Dates
First Submitted
October 1, 2010
First Posted
October 4, 2010
Study Start
June 1, 2009
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
April 27, 2012
Record last verified: 2012-04