Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05885685
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-05-23
Brief Title:
Investigating the Effects of Nabilone on Endocannabinoid Metabolism
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Investigating the Effects of Nabilone on Endocannabinoid Metabolism in the Human Brain
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NABI
Brief Summary:
The purpose of this study is to learn about the effects of a cannabis-like substance nabilone on the levels of endocannabinoid enzyme fatty acid amide hydrolase FAAH in brain of healthy individuals Using magnetic resonance imagine MRI and positron emission tomography PET the main questions we aim to answer are 1 Does nabilone decrease levels of FAAH in the brain and 2 Are changes in levels of FAAH associated with clinical response to nabilone Participants will complete
An in-person interview 4 hours
Two brain imaging scanning sessions 11 hours
A one week 2 mg titrated dose of nabilone
Virtual check-ins up to 15 hours
An in-person interview 4 hours
Two brain imaging scanning sessions 11 hours
A one week 2 mg titrated dose of nabilone
Virtual check-ins up to 15 hours
Detailed Description:
There is limited data regarding the effect of exogenous cannabinoids such as tetrahydrocannabinol THC on the endogenous cannabinoid system eCS Specifically we do not know whether brain levels of fatty acid amide hydrolase FAAH the catabolic enzyme for the endocannabinoid anandamide is affected by sub-chronic THC exposure
Our primary objective is to use positron emission tomography PET imaging of the FAAH probe 11CCURB to test the hypothesis that exposure to nabilone a synthetic THC analogue will reduce FAAH levels in the brain Our secondary objective is to investigate whether reductions in FAAH levels are related to clinical response to nabilone
Participant eligibility will be assessed through a series of questionnaires and assessments on medical family psychiatric and alcohol and drug use history Individuals will also be required to provide blood and urine samples which we will test for recent drug use and pregnancy in female participants Thirty healthy participants will complete one magnetic resonance imaging scan and two PET scans with 11CCURB one at baseline prior to nabilone administration and one approximately 4 weeks apart following a one week 2 mg titrated dose of nabilone Venous and arterial blood draws will be done during PET scans to measure FAAH genotype and plasma radiometabolites respectively Mood assessments will also be administered at these visits During the nabilone dosing period we will meet virtually with participants to check-in and monitor their tolerance and compliance
Understanding whether recent nabilone exposure affects FAAH levels in brain may help to explain variability in clinical response to THC the main psychoactive component in cannabis This information can help guide therapeutic use of cannabis and cannabinoid derivatives and aid in the development of evidence-based medicine targeting the eCS
Our primary objective is to use positron emission tomography PET imaging of the FAAH probe 11CCURB to test the hypothesis that exposure to nabilone a synthetic THC analogue will reduce FAAH levels in the brain Our secondary objective is to investigate whether reductions in FAAH levels are related to clinical response to nabilone
Participant eligibility will be assessed through a series of questionnaires and assessments on medical family psychiatric and alcohol and drug use history Individuals will also be required to provide blood and urine samples which we will test for recent drug use and pregnancy in female participants Thirty healthy participants will complete one magnetic resonance imaging scan and two PET scans with 11CCURB one at baseline prior to nabilone administration and one approximately 4 weeks apart following a one week 2 mg titrated dose of nabilone Venous and arterial blood draws will be done during PET scans to measure FAAH genotype and plasma radiometabolites respectively Mood assessments will also be administered at these visits During the nabilone dosing period we will meet virtually with participants to check-in and monitor their tolerance and compliance
Understanding whether recent nabilone exposure affects FAAH levels in brain may help to explain variability in clinical response to THC the main psychoactive component in cannabis This information can help guide therapeutic use of cannabis and cannabinoid derivatives and aid in the development of evidence-based medicine targeting the eCS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAMHPET-CTA-109 | OTHER | CAMH | None |