Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)
3 other identifiers
interventional
48
1 country
2
Brief Summary
Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia. While a great deal of research has been focused on smoking cessation programs for healthy individuals, little attention has been directed towards developing an effective smoking cessation treatment for schizophrenics. This project will evaluate the effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking non-psychiatric control smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2002
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedJanuary 12, 2017
August 1, 2008
2.7 years
September 16, 2005
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking behavior (measured by automated topography)
after 5 hrs abstinence
Secondary Outcomes (3)
Adverse events (measured by self-report throughout the study)
ongoing
Nicotine withdrawal severity
after 5 hrs abstinence
Smoking urge
after 5 hrs withdrawal
Study Arms (3)
1
EXPERIMENTALTransdermal nicotine, 42 mg
2
EXPERIMENTALTransdermal nicotine, 21 mg
3
PLACEBO COMPARATORplacebo patch
Interventions
Eligibility Criteria
You may qualify if:
- Smokes between 20 and 50 cigarettes per day
- Diagnosis of schizophrenia or schizoaffective disorder
You may not qualify if:
- If enrolled in the control group, must not be diagnosed with a psychiatric disorder
- Currently dependent on alcohol or any drug (other than nicotine)
- Currently trying to quit smoking
- Currently taking bupropion, desipramine, clonidine, buspirone, or doxepin
- History of liver disease
- History of heart attacks or chest pain
- Allergic to adhesives
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Providence VA Medical Center
Providence, Rhode Island, 02908, United States
Brown University
Providence, Rhode Island, 02912, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer W. Tidey
Brown University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
June 1, 2002
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
January 12, 2017
Record last verified: 2008-08