Nicotine Receptor Levels and Smoking Cessation

NCT01788943 | Completed Results DMC

• 1 other identifier: nAChR-PET-quit
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Nicotine Addiction

Keywords

positron emission tomography; nicotine receptor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.

  Before and immediately following the PET scan.

Study Arms (2)

Slow metabolizers

Individuals with an NMR \<0.26 will be classified as slow metabolizers.

Normal metabolizers

Participants with an NMR \>= 0.26 will be classified as normal metabolizers.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria: Participants will be male and female smokers between the ages of 18 and 65 and must be enrolled(consented and meet all eligibility requirements) in the ongoing PNAT trial \[NCT01314001\] in order to participate in this sub-study. They must be able to provide informed consent and weigh less than 300 lbs (due to limitations of the PET and MRI scanners).

You may not qualify if:

• Weigh over 299 lbs.
• Self-reported history of head trauma or brain (or CNS) tumor.
• Self-reported history of claustrophobia (contraindicated for PET and MRI).
• Cochlear implant or bilateral hearing aids.
• Pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for MRI.
• History of gunshot wound (including BB guns).
• Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).
• CO reading greater than 15ppm at the PET Scan Session (or at least a 50% reduction from the PNAT Intake Session).
• BrAC reading greater than or equal to 0.01 at the PET Scan Session.
• 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.
• Positive urine pregnancy (females only) screen at the PET Scan Session and/or MRI Scan Session.
• Inability to give blood at the PET Scan Session (blood samples are required to analyze PET data).
• Any medical condition, illness, disorder or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Co-investigators.
• 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.
• Any physical or visual impairment that would prevent completion of the cognitive tasks.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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. doi: 10.1001/archpsyc.63.8.907.

  PMID: 16894067 BACKGROUND

Related Links

• Principal Investigator
• Center for Interdisplinary Research on Nicotine Addiction
• Position Emission Tomography (PET) Center at the University of Pennsylvania

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Jacob Dubroff,M.D., Ph.D., Assistant Professor of Radiology
• Organization: University of Pennsylvania

jacob.dubroff@uphs.upenn.edu

215-662-3041

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 11, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 12, 2018
• Results First Posted: March 12, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)