NCT02514720

Nicotine Metabolizers and [11C]-(+)-PHNO

Influence of Nicotine Metabolism Ratio on [11C]-(+)-PHNO PET Binding in Tobacco Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	cigarette	Participants will be allowed to smoke a cigarette prior to a PET scan and be abstinent from smoking prior to the other PET scan

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-08-04
• Last updated: 2018-09-12

Locations

1 site across 1 country: Canada