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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

Must not have

History of kidney and/or liver disease per medical record review or self-reported

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of kidney or liver disease.

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I have used or stopped using certain medications like antidepressants or stimulants in the last 2 weeks.

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I drink more than the recommended weekly alcohol limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of abstinence affects brain nAChR availability in smokers

How nicotine administration affects nAChR availability during early abstinence in smokers

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met