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Nicotine Receptor Levels and Smoking Cessation

Nicotinic Receptor Availability and Smoking Cessation Success.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01788943
Enrollment
24
Registered
2013-02-11
Start date
2013-02-28
Completion date
2015-07-31
Last updated
2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Addiction, Smoking Cessation

Keywords

positron emission tomography, nicotine receptor

Brief summary

The investigators propose to use positron emission tomography (PET) imaging to determine whether nicotinic receptor availability at pretreatment predicts smoking cessation success. The investigators will recruit 30 smokers from those enrolled in the Pharmacogenetics of Nicotine Addiction Treatment clinical trial. The investigators will measure nicotinic receptor availability using the PET radioligand 2-\[18F\]FA, after overnight abstinence and prior to initiation of treatment.

Detailed description

Subjects will be asked to complete a short screening session, an orientation phone call, and two imaging sessions: one PET imaging session and one MRI session. Intake Session. This session will familiarize subjects with the study procedures and risks, as well as determine initial eligibility for the study. Subjects will first complete an Imaging Screening Form with study personnel. Subjects will also complete a Magnet Safety Form to check for any metal in the body. Finally, subjects will complete a Scanning Registration Form. Orientation Call. Dr. Dubroff (the Principal Investigator and study physician) will call subjects before the PET Scan Session to review the study procedures and risks and answer any questions subjects might have. PET Scan Session. Subjects will receive a telephone call the day before the session to remind them to stop smoking at 9:00pm that night. At the session, they will provide a series of samples. These include: * A urine sample to assess for the presence of study-prohibited drugs and medications (including cocaine, opiates, benzodiazepines, amphetamines, methamphetamines, tri-cyclic antidepressants, methadone, PCP, and barbiturates). * Women of childbearing age will be required to take a urine pregnancy test. * A breath alcohol concentration (BrAC) measurement. * A breath carbon monoxide (CO) reading. * Have your weight measured. After subjects arrive at the PET center, they will have two intravenous (I.V.) lines placed. A sterile solution will be dripped through the tubing to keep them open. Subjects will have blood pressure and heart rate taken prior to injection and three 10ml tubes of blood will be drawn to determine the baseline levels of radioactive tracer. After this, subjects will be injected with a radioactive tracer (a chemical that has a radioactive molecule attached to it) called 2-\[18F\]FA that will be pumped through one of the I.V. lines over an 8-hour period. During the waiting period subjects will complete two questionnaires, a brief IQ test, and five computer games. They will have repeated blood pressure and heart rate readings taken soon after the initial injection and every 45 minutes afterwards. The investigators will draw 3 ml (half a teaspoon) of blood from the second I.V. line every 15-30 minutes to measure radiotracer levels. Just prior to beginning the scan, subjects will be asked two questions about cravings. These questions will be asked every 30 minutes during the scan and then once more after subjects have exited the scan. The investigators will draw one 3ml tube of blood at the beginning of the PET scan and every 30 min during the PET scan (total 5 teaspoons) from the second I.V. line to measure radiotracer levels.

Interventions

None listed

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Exclusion criteria

In addition to the

Design outcomes

Primary

MeasureTime frameDescription
Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.following overnight nicotine abstinenceAcetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism.

Secondary

MeasureTime frameDescription
Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.Before and immediately following the PET scan.Measure is post-scan subtracted from pre-scan ratings. Rating is measured using the standardized, Questionnaire on Smoking Urges - Brief Version (QSU-Brief) is a standardized measure consisting of 10 statements, each rated on a Likert-like scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Responses for each item are summed to produce an overall score with a range of 10-70.

Countries

United States

Participant flow

Recruitment details

10/01/2012-03/28/2014 recruitment at the Center for Interdisciplinary Research on Nicotine Addiction at the University of Pennsylvania

Participants by arm

ArmCount
Normal Nicotine Metabolizers
Nicotine Metabolite Radio of \> or = 0.26
12
Slow Nicotine Metabolizers
Nicotine Metabolite Radio of \< 0.26.
12
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicNormal Nicotine MetabolizersTotalSlow Nicotine Metabolizers
Age, Continuous48.7 years47.1 years45.5 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants17 Participants9 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants7 Participants3 Participants
Region of Enrollment
United States
12 Participants24 Participants12 Participants
Sex: Female, Male
Female
7 Participants13 Participants6 Participants
Sex: Female, Male
Male
5 Participants11 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 12
other
Total, other adverse events
0 / 130 / 12
serious
Total, serious adverse events
0 / 130 / 12

Outcome results

Primary

Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.

Acetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism.

Time frame: following overnight nicotine abstinence

ArmMeasureValue (MEAN)Dispersion
Slow Metabolizers.Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.17.5 Distribution Volume Ratio (Vt/fp)Standard Deviation 2.4
Normal MetabolizersAcetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.26.8 Distribution Volume Ratio (Vt/fp)Standard Deviation 3.1
p-value: 0.037ANOVA
Secondary

Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.

Measure is post-scan subtracted from pre-scan ratings. Rating is measured using the standardized, Questionnaire on Smoking Urges - Brief Version (QSU-Brief) is a standardized measure consisting of 10 statements, each rated on a Likert-like scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Responses for each item are summed to produce an overall score with a range of 10-70.

Time frame: Before and immediately following the PET scan.

ArmMeasureValue (MEAN)Dispersion
Slow Metabolizers.Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.-8.1 units on a scaleStandard Deviation 10.1
Normal MetabolizersChange in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.1.8 units on a scaleStandard Deviation 7.7
p-value: 0.01t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026