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1. Ages 18 to 65 years old.
2. Smoke 10 cigarettes per day for the previous 6 months.
3. Weigh less than 300lbs (due to limitations of the PET and MRI scanners).
1. Self-reported history of head trauma or brain (or CNS) tumor.
2. Self-reported history of claustrophobia (contraindicated for PET and MRI).
3. Having a cochlear implant or wearing bilateral hearing aids.
4. Self-reported use of pacemakers, certain metallic implants, or presence of metal
in the eye as contraindicated for MRI.
5. History of gunshot wound.
6. Circumstances or conditions that may interfere with magnetic resonance imaging
(MRI)
7. Inability to complete the baseline study procedures within four hours and/or
correctly, as determined by the PI.
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- Philadelphia, Pennsylvania
Descriptive Information | ||||
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Brief Title | Nicotinic Receptor Levels After Stopping Smoking | |||
Official Title | Nicotinic Receptor Availability in Slow and Fast Nicotine Metabolizers | |||
Brief Summary | This positron emission tomography (PET) study examines the effects of 24 hours abstinence from smoking on return to availability of neuronal nicotinic receptors in slow and fast metabolizers of nicotine. | |||
Detailed Description | The nicotine metabolite ratio (NMR), a stable marker of nicotine clearance rate, is a robust predictor of smoking relapse. Individuals who are fast nicotine metabolizers have higher rates of relapse, compared to slow metabolizers, on nicotine replacement or placebo treatment. Nicotine exerts its reinforcing properties, in part, by binding to ?4?2* nicotinic acetylcholine receptors (nAChRs) in the brain. The ?4?2* nAChRs are abundant and have high affinity for nicotine relative to other nAChR subtypes. The goal of this project is to identify abstinence-induced changes in neuronal nicotinic receptor availability that may underlie risk for smoking relapse. The investigators propose to utilize positron emission tomography (PET) imaging to examine the association of variation in nicotine metabolism with return to availability of ?4?2* nAChRs during early abstinence. The investigators will measure ?4?2* receptor availability using the PET radio-ligand 2-[18F]FA, administered with bolus injection, on two separate occasions: during smoking as usual and after 24 hours of abstinence. The proposed study will help us understand the neurochemical mechanisms that underlie the higher risk of relapse among faster nicotine metabolizers, thereby pointing to potential targets for tailored therapy for these smokers at increased risk. In addition, the investigators will invite six subjects who have completed the two PET scans described above to complete a third PET scan. During this third PET scan, the investigators plan to measure ?4?2* receptor availability using the PET radio-ligand 2-[18F]FA, administered as bolus plus constant infusion after 24 hours of abstinence. The purpose will be to compare ?4?2* nAChR binding potential data from the bolus 2-[18F]FA infusion protocol used in the main study to the bolus plus constant infusion protocol used in this third PET scan. The protocol of this third PET scan will help the investigators demonstrate the feasibility at the University of Pennsylvania of administering the radiotracer as a bolus plus constant infusion, and the feasibility of scanning for two hours (versus one hour in the current protocol) paradigm. This data is important pilot data for future NIH grant submissions using this radiotracer. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Two saliva samples will be collected at the medical screening session. A 6ml saliva sample will be used for nicotine metabolite ratio (NMR) estimation, and a 2ml saliva sample for DNA extraction (using an Oragene collection kit). | |||
Sampling Method | Probability Sample | |||
Study Population | 20 adult, non-treatment seeking smokers, reporting consumption of greater than/equal to 10 cigarettes per day for at least 6 months will be the target population for the study. Participants will first be screened over the phone and then complete an in-person medical screen to ensure final eligibility. Enrolled participants will complete 2 PET scans and an MRI scan. 6 smokers who have completed the study and have agreed to be re-contacted for future studies will be invited to participate in an additional procedure. Participants will be screened over the phone and complete an in-person medical screen to ensure final eligibility. Enrolled participants will complete 1 PET scan. | |||
Condition | Nicotine Addiction | |||
Intervention | Drug: 2-[18F]-fluro-3-[2(S)-2-azethidinylmethoxy]-pyridine
The study will be performed using an Investigational New Drug (IND) Application for the 2-[18F]FA radioligand. The 2-[18F]FA radiotracer allows us to measure nicotine receptors. The PET imaging technique used at these sessions allows us to measure the amount of light that 2-[18F]FA gives off in different regions of the brain, we can estimate how many nicotine receptors are in that region. 2-[18F]FA (radiotracer) is investigational, which means it is not approved by the United States Food and Drug Administration (FDA) for the way that it is being used in this research study. For this reason, we have received approval for all procedures in the current study including the use of 2-[18F]FA from the FDA. Other Name: 2-[18F]FA, 2-FA | |||
Study Groups/Cohorts | NMR by abstinence status
This study uses a mixed design with one between-subject factor (NMR: continuous variable) and one within-subject factor (session: 24 hours abstinent vs. smoking as usual) to examine NMR by abstinence status interactions on ?4?2* nAChR availability using 2-[18F]-fluro-3-[2(S)-2-azethidinylmethoxy]-pyridine (2-[18F]FA) PET imaging. Subjects will participate in two one-hour PET sessions: a) after smoking as usual (smoking exposure standardized) and b) the other following 24 hours of smoking abstinence. All participants who complete both PET scans will also complete an anatomical MRI scan. Intervention: Drug: 2-[18F]-fluro-3-[2(S)-2-azethidinylmethoxy]-pyridine | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 20 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | December 2012 | |||
Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01704573 | |||
Other Study ID Numbers | 812051 P50CA143187 ( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement |
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Responsible Party | University of Pennsylvania | |||
Study Sponsor | University of Pennsylvania | |||
Collaborators |
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Investigators |
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PRS Account | University of Pennsylvania | |||
Verification Date | June 2017 |