Status:
ACTIVE_NOT_RECRUITING
Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction
Lead Sponsor:
University of Pennsylvania
Conditions:
Smoking, Tobacco
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Physically healthy adult smokers may be eligible for this study. Volunteers may participate in this study if they are 18 - 65 years old. Subjects will participate in two separate 7-hour PET/CT Scan S...
Eligibility Criteria
Inclusion
- Participants will be 18-65 years of age
- Self-reported cigarette smoking history of at least 10 cigarettes/day for at least 6 months prior to enrollment
- Carbon monoxide reading \> 10 ppm at the initial screening session
- Participants agree to be compliant with all study procedures including smoking abstinence and willingness to complete over-night stays at the Hospital of the University of Pennsylvania
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion
- Women who are pregnant at the time of screening will not be eligible for this study. A urine pregnancy test will be performed in women of childbearing potential at screening.
- Self-reported regular (daily) use of chewing tobacco, snuff or snus
- Current enrollment in a smoking cessation or research program involving the use of nicotine substitutes
- History within one year or currently receiving treatment for substance abuse other than nicotine (e,g,, alcohol, opioids, cocaine, marijuana, or stimulants)
- Current use of cocaine, methamphetamines or other psychoactive substances per self-report and/or positive urine drug screen at the initial screening session
- Self-reported current alcohol consumption that exceeds greater than 25 drinks per week in men and 18 drinks per week in women
- BrAC reading greater than or equal to 0.01% at the initial screening session
- History of kidney and/or liver disease per medical record review or self-reported
- Uncontrolled hypertension (defined as Systolic BP \> 160 and/or Diastolic BP \> 100 at the screening intake session)
- History of Posttraumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or other psychotic disorder or Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by medical record review and/or self-report. History of unipolar depression or anxiety disorder may be accepted; current depression or anxiety may be accepted if the severity does not require psychoactive medication as assessed by medical record review and/or self-report.
- History of head trauma, that in the opinion of an investigator may interfere with the uptake of \[18F\]2-FA, as assessed by medical record review and/or self-report
- Current use or recent discontinuation (within the last 14 days) of any of the following:
- Smoking cessation medication (e.g. Zyban, Wellbutrin, Wellbutrin SR, Chantix).
- Anti-psychotic medications.
- Certain medications used to treat depression, including SSRIs, Wellbutrin, MAOIs, and tricyclic antidepressants.
- Prescription stimulants (e.g. Provigil, Ritalin, Adderall).
- Current use of any of the following:
- Nicotine replacement therapy (NRT).
- Tagamet (cimetidine).
- Heart medications such as digoxin, quinidine, nitroglycerin. Use of these medications may result in ineligibility and will therefore be evaluated on a case-by-case basis by the Study Physician.
- Anti-coagulants (e.g. Coumadin, Warfarin).
- Any drug the investigator determines could interfere with scan results.
- Daily use of any of the following:
- Opiate-containing medications for chronic pain; If a participant reports taking an opiate-containing medication every day for the 14 days prior to the telephone screen and/or the Intake Session, the participant will be ineligible.
- Rescue Inhalers (e.g. Albuterol, Proventil, Ventolin, or Maxair).
- Any contraindication to brain MRI
- Any current medical condition, psychiatric disorder, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2026
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03442413
Start Date
June 28 2018
End Date
November 22 2026
Last Update
January 31 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104