NCT02514720

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 12, 2018

Status Verified

June 1, 2017

Enrollment Period

1.6 years

First QC Date

July 30, 2015

Last Update Submit

September 10, 2018

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Study Arms (2)

Fast Nicotine Metabolizers

OTHER

Those in the upper tertile of NMR for cigarette/nicotine metabolism.

Other: cigarette

Slow Nicotine Metabolizers

OTHER

Those in the lower tertile of NMR for cigarette/nicotine metabolism

Other: cigarette

Interventions

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

Fast Nicotine MetabolizersSlow Nicotine Metabolizers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 1S8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29346545BACKGROUND

Related Links

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Bernard Le Foll, MD, PHD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Translational Addiction Research Laboratory

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 4, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 12, 2018

Record last verified: 2017-06

Locations

CA(1)