Smoking Cessation Clinical Trial
Official title:
Nicotinic Receptor Availability and Smoking Cessation Success.
Verified date | August 2017 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators propose to use positron emission tomography (PET) imaging to determine whether nicotinic receptor availability at pretreatment predicts smoking cessation success. The investigators will recruit 30 smokers from those enrolled in the Pharmacogenetics of Nicotine Addiction Treatment clinical trial. The investigators will measure nicotinic receptor availability using the PET radioligand 2-[18F]FA, after overnight abstinence and prior to initiation of treatment.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Exclusion Criteria: In addition to the exclusion criteria used for PNAT trial [NCT01314001], participants in this trial will be excluded if they meet the following criteria: Imaging-Related Exclusion Criteria: 1. Weigh over 299 lbs. 2. Self-reported history of head trauma or brain (or CNS) tumor. 3. Self-reported history of claustrophobia (contraindicated for PET and MRI). 4. Cochlear implant or bilateral hearing aids. 5. Pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for MRI. 6. History of gunshot wound (including BB guns). 7. Circumstances or conditions that may interfere with magnetic resonance imaging (MRI). 8. CO reading greater than 15ppm at the PET Scan Session (or at least a 50% reduction from the PNAT Intake Session). 9. BrAC reading greater than or equal to 0.01 at the PET Scan Session. 10. Positive urine drug screen for cocaine, phencyclidine, amphetamines, methamphetamines, tricyclic antidepressants, opiates, methadone, benzodiazepines, or barbiturates at the PNAT Intake Session or PET Scan Session. 11. Positive urine pregnancy (females only) screen at the PET Scan Session and/or MRI Scan Session. 12. Inability to give blood at the PET Scan Session (blood samples are required to analyze PET data). 13. Prior exposure to radioactive tracers in imaging studies or for medical reasons may be exclusionary. General Exclusion Criteria: 1. Any medical condition, illness, disorder or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Co-investigators. 2. Inability to provide informed consent or complete the study procedures within 10 hours and/or correctly, as determined by the Principal Investigator or Co-investigators. 3. Any physical or visual impairment that would prevent completion of the cognitive tasks. 4. Participation (within the last 6 months) in other studies at our center involving similar cognitive testing procedures. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Brody AL, Mandelkern MA, London ED, Olmstead RE, Farahi J, Scheibal D, Jou J, Allen V, Tiongson E, Chefer SI, Koren AO, Mukhin AG. Cigarette smoking saturates brain alpha 4 beta 2 nicotinic acetylcholine receptors. Arch Gen Psychiatry. 2006 Aug;63(8):907-15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging. | Acetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism. | following overnight nicotine abstinence | |
Secondary | Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges. | Measure is post-scan subtracted from pre-scan ratings. Rating is measured using the standardized, Questionnaire on Smoking Urges - Brief Version (QSU-Brief) is a standardized measure consisting of 10 statements, each rated on a Likert-like scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Responses for each item are summed to produce an overall score with a range of 10-70. | Before and immediately following the PET scan. |
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