Trials Sponsors Conditions Drugs Pricing

Conditions

Smoking, Tobacco

Outcome Measures

Primary Outcomes (2)

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)).
2 years
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).
2 years

Secondary Outcomes (1)

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

Study Arms (1)

2-[18F]-FA PET/CT

EXPERIMENTAL

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

Drug: 2-[18F]-FA PET/CTDrug: I.V. Nicotine

Interventions

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.

2-[18F]-FA PET/CT

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.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

University of Pennsylvania
Otherlead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Enrollment

13 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 22, 2018

Study Start

June 28, 2018

Actual (reported)

Primary Completion

You may not qualify if:

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.
+12 more criteria

Nicotinic Hepatic Metabolism on Neuroreceptor Substrates of Nicotine Addiction

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

2-[18F]-FA PET/CT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

2-[18F]-FA PET/CT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations