Overview

Nicotine Receptor Levels and Smoking Cessation

Status:
Completed
Trial end date:
0000-00-00
Target enrollment:
24
Participant gender:
Both
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Pennsylvania
Treatments:
Nicotine
Last Updated:
2015-11-30
Criteria
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).

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.