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Smoking, TobaccoPhase 1NCT03442413

Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction

A Phase 1 study testing 2-[18F]-FA PET/CT and I.V. Nicotine in people with Smoking, Tobacco, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Sessions (each with 2 hours of actual PET/CT scanning): one following an overnight abstinence and one following two… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Smoking, Tobacco
What is being tested?
2-[18F]-FA PET/CT and I.V. Nicotine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
28 Jun 2018to 22 Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: The Influence of Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction

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 Sessions (each with 2 hours of actual PET/CT scanning): one following an overnight abstinence and one following two overnights of abstinence. To achieve and confirm two overnights of abstinence, participants will present to the inpatient CHPS the day prior to the scheduled scan and stay overnight.

Read more

The 2-[18F]-FA PET/CT brain scans will consist of an injection followed by an 7-hour infusion of 2-[18F]-FA. The scan session will begin at approximately 4 hours after the bolus injection. The PET/CT scan will occur in two segments. Starting at approximately 4 hours post bolus and infusion start, we will scan for approximately 90 minutes with a bolus injection of IV nicotine that will occur approximately 15 minutes into the scanning procedure. There will be a break in scanning of approximately 60 minutes, during which subjects will be allowed to get off the scanner and use the restroom, if necessary. The second scan segment will start at approximately 6.5 hours post bolus injection, t. This segment will last approximately 30 minutes. The pre and post nicotine images will be analyzed to evaluate for differences in receptor uptake after the nicotine "challenge".

Subjects will have a structural Brain MRI performed within 1 year prior to study enrollment or subjects who have not had a Brain MRI that is deemed acceptable for use for this study will undergo a research Brain MRI after consent.

Being tested
2-[18F]-FA PET/CT, I.V. Nicotine
Medical subject headings
Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2-[18F]-FA PET/CTDrug

    2-[18F]FA is a highly specific radiotracer which has been used successfully to image nicotinic acetylcholine receptors in the human brain to characterize the effects of nicotine exposure (via smoking) on these receptors.

  • I.V. NicotineDrug

    Subjects in our study will receive intravenous nicotine at the adaptation session and each of the PET scans, close to the amount of nicotine absorbed from smoking 1/10 cigarette.

Study groups in NCT03442413
Study groupRoleWhat they receive
2-[18F]-FA PET/CTExperimentalSubjects will participate in two separate 10-hour PET/CT Scan Sessions (each with 2 hours of actual PET/CT scanning): one following an overnight abstinence and one following two overnights of abstinence. To achieve and confirm two overnights of abstinence, participants will present to the inpatient CHPS the day prior to the scheduled scan and stay overnight
Receives: Drug: 2-[18F]-FA PET/CT; Drug: I.V. Nicotine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of abstinence affects brain nAChR availability in smokers

    To determine how duration of abstinence affects brain nAChR availability in smokers who metabolize nicotine at slow and normal rates (measured by the nicotine-metabolite ratio (NMR)).

    Measured: 2 years

  2. How nicotine administration affects nAChR availability during early abstinence in smokers

    To compare how nicotine administration affects nAChR availability during early abstinence in smokers who metabolize nicotine at slow and normal rates (measured by the NMR).

    Measured: 2 years

Secondary outcomes (1)

  1. Standard measures of cigarette craving and withdrawal to nAChR availability in smokers

    To correlate standard measures of cigarette craving and withdrawal to nAChR availability in smokers who metabolize nicotine at slow and normal rates (measured by the NMR) who are abstinent, before and after administration of IV nicotine

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start28 Jun 2018
  3. Primary completion22 Nov 2026 (estimated)
  4. Study completion22 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03442413
Sponsor's protocol ID
828090
Status last verified
Feb 2026
First submitted
16 Feb 2018
Last updated
3 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 2-[18F]-FA PET/CT and I.V. Nicotine in people with Smoking, Tobacco, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of abstinence affects brain nAChR availability in smokers (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03442413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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