N/A
N=25
Nicotine Receptor Levels and Smoking Cessation
Smoking Cessation · Nicotine Addiction
Bottom Line
View on ClinicalTrials.gov: NCT01788943 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging. — 17.5; 26.8 Distribution Volume Ratio (Vt/fp) — p=0.037
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging. |
17.5; 26.8 | 0.037 sig |
| SECONDARY Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges. |
-8.1; 1.8 | 0.01 sig |
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.
Eligibility Criteria
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:
- 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).
- Prior exposure to radioactive tracers in imaging studies or for medical reasons may be exclusionary.
General Exclusion Criteria:
- 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.
- Participation (within the last 6 months) in other studies at our center involving similar cognitive testing procedures.
Data sourced from ClinicalTrials.gov (NCT01788943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.