- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01526005
Brain Nicotine Receptor Density & Response to Nicotine Patch
January 26, 2015 updated by: Arthur Brody, Brentwood Biomedical Research Institute
Even though the health risks and societal costs of cigarette smoking are well-known, roughly 19.8% of American adults continue to smoke.
While most smokers endorse a desire to quit, very few (< 5%) will actually quit in a given year without treatment, and only about 20-25% achieve abstinence after 6 months or more of effective treatment.
Therefore, there continues to be a vital need to improve outcomes for cigarette smokers seeking treatment.
Current first-line medications for Tobacco Dependence include nicotine replacement therapies (such as the patch, gum, lozenge, nasal spray, and inhaler), varenicline HCl (Chantix), and bupropion HCl (Zyban), with the current standard of care in most treatment settings being to choose specific medications based primarily on availability, ease of use, and patient preference.
The goal of the proposed research is to improve the delivery of smoking cessation treatment by determining if pre-treatment nicotine receptor density in cigarette smokers is associated with smoking cessation outcome with the standard nicotine patch taper.
The study's main hypothesis is that cigarette smokers with less pre-treatment upregulation of nicotine receptors will have a greater likelihood of quitting smoking from a standard course of nicotine patch treatment than smokers with more up-regulation of these receptors.
Positron emission tomography (PET) will be used to test this hypothesis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
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
-
-
California
-
Los Angeles, California, United States, 90073
- West Los Angeles Veterans Affairs 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 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Tobacco dependent cigarette smokers will be recruited through newspaper and internet advertisements from populations living in the counties surrounding the West Los Angeles Veterans Affairs Medical Center.
Description
Inclusion Criteria:
- Healthy adult who is a tobacco dependent smoker (smokes 10-30 cigarettes per day) meeting criteria for Nicotine Dependence as defined by DSM-IV criteria
- Has the desire to quit smoking
- Ability to read, write, and give voluntary informed consent
- An exhaled CO greater than or equal to 8 ppm during the study screening visit to verify smoking status
Exclusion Criteria:
- Any history of an Axis I psychiatric diagnosis other than Nicotine Dependence (including other substance abuse/dependence and mood, anxiety, and psychotic disorders)
- Any current medication or any history of a medical condition that might affect the central nervous system at the time of scanning (e.g., current treatment with a psychotropic medication, or history of severe head trauma or epilepsy).
- Unstable cardiovascular disease, liver disease, or renal insufficiency. Routine history and physical examination will be performed at the initial screening visit to insure that participants meet study criteria
- Pregnancy (urine pregnancy tests will be obtained on all women of child-bearing potential) due to the theoretical risk of radiation exposure to the fetus. Pre-menopausal women will only be scanned during the early follicular phase (by participant report) of the menstrual cycle because hormonal levels have been shown to affect nicotine metabolism.
- Caffeine dependence, as evidenced by withdrawal symptoms temporally associated with caffeine ingestion.
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Active agent (nicotine patch)
|
1 patch per day; dosages of 21 mg/day for 4 weeks, 14 mg/day for 2 weeks, and 7 mg/day for 2 weeks; 8 weeks total
|
Placebo patch
|
1 patch per day; 8 weeks total
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PET scanning
Time Frame: 2/12-2/14
|
Brain imaging used to predict response to smoking cessation treatment
|
2/12-2/14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
August 29, 2011
First Submitted That Met QC Criteria
February 1, 2012
First Posted (Estimate)
February 3, 2012
Study Record Updates
Last Update Posted (Estimate)
January 27, 2015
Last Update Submitted That Met QC Criteria
January 26, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0015
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.
Clinical Trials on Cigarette Smoking
-
Maastricht University Medical CenterCompletedCigarette Smoking | Cigarette Smoking Toxicity | Smoking BehaviorNetherlands
-
Duke UniversityGeorgetown University; University of MichiganWithdrawnSmoking | Cigarette Smoking | E-cigarette Use
-
Assistance Publique - Hôpitaux de ParisUnknownSmoking Cessation | Smoking, Cigarette | Electronic CigaretteFrance
-
Yale UniversityNational Cancer Institute (NCI)RecruitingSmoking Cessation | Cigarette Smoking | E-Cigarette UseUnited States
-
Medical University of South CarolinaAmerican Cancer Society, Inc.RecruitingSmoking Cessation | Electronic Cigarette Use | Cigarette SmokingUnited States
-
Abramson Cancer Center of the University of PennsylvaniaNational Cancer Institute (NCI); New York University; Stanford UniversityRecruitingSmoking | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of St AndrewsNational Health Service, United KingdomUnknownSmoking | Cigarette Smoking | Smoking, Tobacco
-
BIDI VaporCompletedCigarette Smoking | E-cigarette UsePoland
-
University GhentRecruitingSmoking | Smoking Tobacco | Smoking Prevention | Smoking CigaretteBelgium
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
Clinical Trials on Transdermal Nicotine Patch
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedTobacco Use DisorderUnited States
-
National Institute on Drug Abuse (NIDA)CompletedSchizophrenia | Tobacco Use Disorder | Schizophrenia and Disorders With Psychotic FeaturesUnited States
-
Massachusetts General HospitalStanley Medical Research Institute; North Suffolk Mental Health AssociationCompleted
-
James BOYD MDMichael J. Fox Foundation for Parkinson's Research; Philipps University Marburg... and other collaboratorsUnknownParkinson's DiseaseUnited States, Germany
-
Duke UniversityShireCompletedAttention Deficit Hyperactivity Disorder | Nicotine DependenceUnited States
-
Vanderbilt University Medical CenterCompletedDown Syndrome | Mild Cognitive ImpairmentUnited States
-
University of VirginiaRecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking, Cigarette | Quitting SmokingUnited States
-
Assistance Publique - Hôpitaux de ParisCompleted
-
National Institute on Aging (NIA)Unknown