- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218218
Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)
Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60 percent of schizophrenics smoke cigarettes.
Nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking.
Little research has been done on the most effective way to control nicotine use in schizophrenic individuals.
Transdermal nicotine and bupropion reduce smoking in non-psychiatric smokers, but little is known about the effects of these medications in smokers with schizophrenia.
This project examines the effects of 0, 21 and 42 mg transdermal nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking controls.
Participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied.
After 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues.
This is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
Providence, Rhode Island, United States, 02908
- Providence VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Smokes between 20 and 50 cigarettes per day
- Diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Transdermal nicotine, 42 mg
|
42 mg transdermal nicotine
Other Names:
|
Experimental: 2
Transdermal nicotine, 21 mg
|
Other Names:
|
Placebo Comparator: 3
placebo patch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Smoking behavior (measured by automated topography)
Time Frame: after 5 hrs abstinence
|
after 5 hrs abstinence
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events (measured by self-report throughout the study)
Time Frame: ongoing
|
ongoing
|
Nicotine withdrawal severity
Time Frame: after 5 hrs abstinence
|
after 5 hrs abstinence
|
Smoking urge
Time Frame: after 5 hrs withdrawal
|
after 5 hrs withdrawal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer W. Tidey, Brown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
September 16, 2005
First Submitted That Met QC Criteria
September 16, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Schizophrenia
- Disease
- Tobacco Use Disorder
- Schizophrenia Spectrum and Other Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- NIDA-14002-1
- DPMC (Other Identifier: NIDA)
- R01-14002-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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