Nicotine DependenceMETNCT02514720
Nicotine Metabolizers and [11C]-(+)-PHNO
A study testing cigarette in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the effects of nicotine metabolism on occupancy of [11C]-(+)-PHNO to DA 2/3 receptors in different brain areas during periods of abstinence and smoking during an abstinence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females of any ethnic origin 18 years of age or older.
- No previous use of medication for smoking cessation in previous month-
- Non-treatment seeker
- Either SMs or FMs by NMR
Who cannot join
- DSM-IV diagnosis of other drug dependences
- Any medical condition requiring immediate investigation or treatment
- Pregnancy tested by urine or lactation by self-report
- Current diagnosis of any Axis I psychiatric disorder
- Regular use of any therapeutic or recreational psychoactive drug use that may interfere with PET scanning
- Exposure to radiation in the last 12 months exceding permissible limit for participants participating in research
Show all 11Show fewer
- Current use of medication that may interfere with [11C]-(+)-PHNO
- Metal implants or paramagnetic objects within the body which may interfere with the MRI
- Claustrophobia or a history of panic attacks
- Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study
- Current use of antidepressants that may inhibit CYP2A6 or impact response to nicotine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Nicotine Metabolism Ratio on [11C]-(+)-PHNO PET Binding in Tobacco Smokers
The purpose of this study is to investigate the effects of nicotine metabolism on occupancy of [11C]-(+)-PHNO to DA 2/3 receptors in different brain areas during periods of abstinence and smoking during an abstinence. This will be a Positron Emission Tomography (PET) study and the radiotracer [11C]-(+)-PHNO (11C]-( + )-4-propyl- 3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol) will be used.
Read the detailed description
The participants will undergo a PET scan after approximately 48 hours abstinence (to ensure total elimination of nicotine in both FMs and SMs) and then approximately >5 hours later may have a second PET scan after smoking their preferred cigarette (approximately 1 hour before). It is possible that these two scans may also occur on separate days. All subjects will provide a urine sample for (1) drug toxicology, (2) pregnancy test (in females) and (3) Total Nicotine Equivalents (TNE: a measure of total consumption unaltered by rate of nicotine metabolism). There will one blood draw taken before and one after each PET scan (about 20mls in total) to measure nicotine and COT levels (to assess abstinence) as well as kinetics of nicotine delivery. Participants will be given questionnaires prior to, or during, and/or after one or both of the PET scans to determine differences between abstinence and smoking on subjective measures..
- Conditions
- Nicotine Dependence
- Being tested
- cigarette
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cigaretteOther
Participants will be allowed to smoke a cigarette prior to a PET scan and be abstinent from smoking prior to the other PET scan
| Study group | Role | What they receive |
|---|---|---|
| Fast Nicotine Metabolizers | Other | Those in the upper tertile of NMR for cigarette/nicotine metabolism. Receives: Other: cigarette |
| Slow Nicotine Metabolizers | Other | Those in the lower tertile of NMR for cigarette/nicotine metabolism Receives: Other: cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupancy of D2/3 receptors by [11C]-(+)-PHNO
Fast and slow nicotine metabolizers will have PET scans and occupancy of dopamine receptors will be measured using a PET scanner.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Bernard Le Foll, MD, PHD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514720
- Sponsor's protocol ID
- 111/2014
- Acronym
- MET
- Status last verified
- Jun 2017
- First submitted
- 30 Jul 2015
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Di Ciano P, Tyndale RF, Mansouri E, Hendershot CS, Wilson AA, Lagzdins D, Houle S, Boileau I, Le Foll B. Influence of Nicotine Metabolism Ratio on [11C]-(+)-PHNO PET Binding in Tobacco Smokers. Int J Neuropsychopharmacol. 2018 Jun 1;21(6):503-512. doi: 10.1093/ijnp/pyx119.
PubMed 29346545
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Nicotine Metabolism Ratio on [11C]-(+)-PHNO PET Binding in Tobacco Smokers
- ClinicalTrials.gov ID
- NCT02514720
- Acronym / sponsor ID
- MET / 111/2014
- Conditions
- Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of nicotine metabolism on occupancy of [11C]-(+)-PHNO to DA 2/3 receptors in different brain areas during periods of abstinence and smoking during an abstinence. This will be a Positron Emission Tomography (PET) study and the radiotracer [11C]-(+)-PHNO (11C]-( + )-4-propyl- 3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol) will be used.
Detailed description
The participants will undergo a PET scan after approximately 48 hours abstinence (to ensure total elimination of nicotine in both FMs and SMs) and then approximately >5 hours later may have a second PET scan after smoking their preferred cigarette (approximately 1 hour before). It is possible that these two scans may also occur on separate days. All subjects will provide a urine sample for (1) drug toxicology, (2) pregnancy test (in females) and (3) Total Nicotine Equivalents (TNE: a measure of total consumption unaltered by rate of nicotine metabolism). There will one blood draw taken before and one after each PET scan (about 20mls in total) to measure nicotine and COT levels (to assess abstinence) as well as kinetics of nicotine delivery. Participants will be given questionnaires prior to, or during, and/or after one or both of the PET scans to determine differences between abstinence and smoking on subjective measures..
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast Nicotine Metabolizers | Other | Other: cigaretteThose in the upper tertile of NMR for cigarette/nicotine metabolism. |
| Slow Nicotine Metabolizers | Other | Other: cigaretteThose in the lower tertile of NMR for cigarette/nicotine metabolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females of any ethnic origin 18 years of age or older.
- No previous use of medication for smoking cessation in previous month-
- Non-treatment seeker
- Either SMs or FMs by NMR
Key exclusion criteria (11 listed)
- DSM-IV diagnosis of other drug dependences
- Any medical condition requiring immediate investigation or treatment
- Pregnancy tested by urine or lactation by self-report
- Current diagnosis of any Axis I psychiatric disorder
- Regular use of any therapeutic or recreational psychoactive drug use that may interfere with PET scanning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cigaretteParticipants will be allowed to smoke a cigarette prior to a PET scan and be abstinent from smoking prior to the other PET scan | Other | Fast Nicotine Metabolizers, Slow Nicotine Metabolizers |
Primary outcome
Occupancy of D2/3 receptors by [11C]-(+)-PHNO
Time frame: 2 weeks
Fast and slow nicotine metabolizers will have PET scans and occupancy of dopamine receptors will be measured using a PET scanner.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Background: PubMed 29346545Di Ciano P, Tyndale RF, Mansouri E, Hendershot CS, Wilson AA, Lagzdins D, Houle S, Boileau I, Le Foll B. Influence of Nicotine Metabolism Ratio on [11C]-(+)-PHNO PET Binding in Tobacco Smokers. Int J Neuropsychopharmacol. 2018 Jun 1;21(6):503-512. doi: 10.1093/ijnp/pyx119.
- Published data may be found at site above and PMID 29346545Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Nicotine Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruitingObservational study
Neurostructural and Biochemical Signatures of Tobacco Smoking in Mood Disorders
Major Depressive Disorder, Bipolar Disorder
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
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.
Bernard Le Foll, MD, PHD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cigarette in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 4 inclusion and 11 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 Sep 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occupancy of D2/3 receptors by [11C]-(+)-PHNO (time frame: 2 weeks). 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 NCT02514720, 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 Sep 2018.