Smoking CessationNCT01788943
Nicotine Receptor Levels and Smoking Cessation
An observational study of Smoking Cessation and Nicotine Addiction, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Nicotine Addiction
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jul 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Inclusion Criteria: Participants will be male and female smokers between the ages of 18 and 65 and must be enrolled(consented and meet all eligibility requirements) in the ongoing PNAT trial [NCT01314001] in order to participate in this sub-study. They must be able to provide informed consent and weigh less than 300 lbs (due to limitations of the PET and MRI scanners).
Who may be able to join
None listed.
Who cannot join
- In addition to the exclusion criteria used for PNAT trial [NCT01314001], participants in this trial will be excluded if they meet the following criteria:
- Imaging-Related Exclusion Criteria:
- Weigh over 299 lbs.
- Self-reported history of head trauma or brain (or CNS) tumor.
- Self-reported history of claustrophobia (contraindicated for PET and MRI).
- Cochlear implant or bilateral hearing aids.
Show all 20Show fewer
- Pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for MRI.
- History of gunshot wound (including BB guns).
- Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).
- CO reading greater than 15ppm at the PET Scan Session (or at least a 50% reduction from the PNAT Intake Session).
- BrAC reading greater than or equal to 0.01 at the PET Scan Session.
- Positive urine drug screen for cocaine, phencyclidine, amphetamines, methamphetamines, tricyclic antidepressants, opiates, methadone, benzodiazepines, or barbiturates at the PNAT Intake Session or PET Scan Session.
- Positive urine pregnancy (females only) screen at the PET Scan Session and/or MRI Scan Session.
- Inability to give blood at the PET Scan Session (blood samples are required to analyze PET data).
- Prior exposure to radioactive tracers in imaging studies or for medical reasons may be exclusionary.
- General Exclusion Criteria:
- Any medical condition, illness, disorder or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Co-investigators.
- Inability to provide informed consent or complete the study procedures within 10 hours and/or correctly, as determined by the Principal Investigator or Co-investigators.
- Any physical or visual impairment that would prevent completion of the cognitive tasks.
- Participation (within the last 6 months) in other studies at our center involving similar cognitive testing procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Nicotinic Receptor Availability and Smoking Cessation Success.
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.
Read the 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.
- Conditions
- Smoking Cessation, Nicotine Addiction
- Keywords
- positron emission tomography, nicotine receptor
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Slow metabolizers | Individuals with an NMR <0.26 will be classified as slow metabolizers. | |
| Normal metabolizers | Participants with an NMR >= 0.26 will be classified as normal metabolizers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: following overnight nicotine abstinence
Secondary outcomes (1)
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.
Measured: Before and immediately following the PET scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Dubroff, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788943
- Sponsor's protocol ID
- nAChR-PET-quit
- Status last verified
- Aug 2017
- First submitted
- 7 Feb 2013
- Last updated
- 12 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Brody AL, Mandelkern MA, London ED, Olmstead RE, Farahi J, Scheibal D, Jou J, Allen V, Tiongson E, Chefer SI, Koren AO, Mukhin AG. Cigarette smoking saturates brain alpha 4 beta 2 nicotinic acetylcholine receptors. Arch Gen Psychiatry. 2006 Aug;63(8):907-15. doi: 10.1001/archpsyc.63.8.907.
PubMed 16894067
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinic Receptor Availability and Smoking Cessation Success.
- ClinicalTrials.gov ID
- NCT01788943
- Acronym / sponsor ID
- nAChR-PET-quit
- Conditions
- Smoking Cessation, Nicotine Addiction
- Keywords
- positron emission tomography, nicotine receptor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Posted 12 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow metabolizers | – | –Individuals with an NMR <0.26 will be classified as slow metabolizers. |
| Normal metabolizers | – | –Participants with an NMR >= 0.26 will be classified as normal metabolizers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: Participants will be male and female smokers between the ages of 18 and 65 and must be enrolled(consented and meet all eligibility requirements) in the ongoing PNAT trial [NCT01314001] in order to participate in this sub-study. They must be able to provide informed consent and weigh less than 300 lbs (due to limitations of the PET and MRI scanners).
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- In addition to the exclusion criteria used for PNAT trial [NCT01314001], participants in this trial will be excluded if they meet the following criteria:
- Weigh over 299 lbs.
- Self-reported history of head trauma or brain (or CNS) tumor.
- Self-reported history of claustrophobia (contraindicated for PET and MRI).
- Cochlear implant or bilateral hearing aids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.
Time frame: following overnight nicotine abstinence
Acetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism.
1 secondary outcome
Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.
Time frame: Before and immediately following the PET scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16894067Brody AL, Mandelkern MA, London ED, Olmstead RE, Farahi J, Scheibal D, Jou J, Allen V, Tiongson E, Chefer SI, Koren AO, Mukhin AG. Cigarette smoking saturates brain alpha 4 beta 2 nicotinic acetylcholine receptors. Arch Gen Psychiatry. 2006 Aug;63(8):907-15. doi: 10.1001/archpsyc.63.8.907.
- Principal InvestigatorLink provided by the sponsor.
- Center for Interdisplinary Research on Nicotine AddictionLink provided by the sponsor.
- Position Emission Tomography (PET) Center at the University of PennsylvaniaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Nicotine Addiction, 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 0 inclusion and 20 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: finished, as of the sponsor's last update on 12 Mar 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging. (time frame: following overnight nicotine abstinence). 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 NCT01788943, which also lists 1 linked publication.
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 12 Mar 2018.