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I.V. Nicotine for Smoking Addiction

Phase 1
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is for physically healthy adult smokers who are willing to be abstinent for two nights. They will have a PET/CT scan after the first night and another PET/CT scan after the second night, with a break in between for about 60 minutes. There will be a bolus injection of nicotine during the second scan.

Who is the study for?
Adult smokers aged 18-65 who smoke at least 10 cigarettes a day for the past 6 months and have a carbon monoxide reading over 10 ppm. They must be willing to stay overnight in the hospital and abstain from smoking as required. Pregnant women, heavy alcohol drinkers, those with liver/kidney disease or high blood pressure, or users of certain medications are excluded.Check my eligibility
What is being tested?
The study tests how nicotine affects brain receptors in smokers using PET/CT scans after periods of abstinence. Participants will undergo two separate scan sessions with an injection and infusion of a tracer substance followed by IV nicotine during one session to compare receptor uptake before and after nicotine exposure.See study design
What are the potential side effects?
Potential side effects may include discomfort from needle injections for IVs and tracers, reactions to the substances used during PET/CT scans such as allergic reactions or nausea, anxiety from confinement during scanning procedures, and possible side effects from temporary nicotine withdrawal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have smoked at least 10 cigarettes a day for 6 months or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of abstinence affects brain nAChR availability in smokers
How nicotine administration affects nAChR availability during early abstinence in smokers
Secondary outcome measures
Standard measures of cigarette craving and withdrawal to nAChR availability in smokers

Trial Design

1Treatment groups
Experimental Treatment
Group I: 2-[18F]-FA PET/CTExperimental Treatment2 Interventions
Subjects 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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,867 Total Patients Enrolled

Media Library

2-[18F]-FA PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT03442413 — Phase 1
Tobacco Smoking Research Study Groups: 2-[18F]-FA PET/CT
Tobacco Smoking Clinical Trial 2023: 2-[18F]-FA PET/CT Highlights & Side Effects. Trial Name: NCT03442413 — Phase 1
2-[18F]-FA PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03442413 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research open to geriatric participants?

"This medical trial is open to any individual between the ages of 18 and 65."

Answered by AI

Are there still openings for participants in this research initiative?

"Yes, the data located on clinicaltrials.gov confirms that this research initiative is still recruiting participants. The trial was first made public on June 28th 2018 and has since been updated as recently as February 11th 2022. So far, 30 individuals have had to be enrolled from one medical facility ."

Answered by AI

Who meets the qualifications to participate in this clinical investigation?

"This clinical study seeks 30 volunteers who are addicted to tobacco products, aged 18-65. Specifically, applicants must have been smoking at least 10 cigarettes per day for a minimum of six months prior to joining the trial along with agreement on prescribed procedures such as abstaining from nicotine and overnight hospital stays at the Hospital of the University of Pennsylvania."

Answered by AI

What is the current number of participants enrolled in this research study?

"That is correct. According to public records published on clinicaltrials.gov, this investigation commenced on June 28th 2018 and remains open for recruitment as of February 11th 2022. 30 participants are being sought from one medical centre."

Answered by AI

Have any further investigations been conducted using 2-[18F]-FA PET/CT as a diagnostic tool?

"Presently, 71 trials related to 2-[18F]-FA PET/CT are ongoing with 5 in their final stages. The bulk of these tests are occurring in Green Bay, Wisconsin though 204 different clinical sites across the country have joined this research effort."

Answered by AI

Has the United States Food and Drug Administration sanctioned 2-[18F]-FA PET/CT?

"Our team has assigned 2-[18F]-FA PET/CT a score of 1 due to the fact that this is an early trial, with limited evidence found in favor of safety and efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction
2018. "Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03442413.
All > Opiate Addiction > Addiction
~3 spots leftby Nov 2025
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