CBD-65: Knowledges and Use of Cannabidiol in Older Adults

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06094582

Collaborator

(none)

140

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The use of non-medical cannabidiol (CBD) has been growing recently in France and in the world, in young but also older adults. Few data are available on the use of cannabidiol in older adults. A better knowledge of the use of cannabidiol in older adults, and of their own knowledges of the molecule, is necessary to guide and follow the CBD uptake in this population and avoid potential adverse events.

Condition or Disease	Intervention/Treatment	Phase
Aging Frailty	Other: questionnaire

Detailed Description

Cannabidiol may be used by patients because it may have beneficial pharmacological effects (including anxiolytic, analgesic, anti-inflammatories or antioxidant effects). Older adults aged 65 years and over, are more frequently at risk of multimorbidity and loss of autonomy, and may present with several symptoms like pain, anxiety, sleep disturbances, that may potentially respond to CBD. The molecule is often marketed as devoid of adverse effects. Nevertheless, with ageing, reduction in liver and kidney function, may have an impact on the metabolism and elimination of CBD and increase the risk of side-effect. As well, the risk of interaction with drugs frequently prescribed in older adults such as CYP3A4 inhibitors (verapamil, ketoconazole …), CYP3A4 inducers (phenytoin, carbamazepine, …) or CY92C19 inhibitors or inducers (fluoxetine …), may increase the risk of side effects. Our hypothesis is that the use of CBD has increased last years in older adults, but that they are insufficiently informed about this molecule. There is a need to assess the prevalence of CBD use in older adults in France, to assess the knowledges of CBD users about this substance, and to better characterize CBD users.

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Knowledges and Use of Cannabidiol in Older Adults Aged 65 Years and Over in France

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Outcome Measures

Primary Outcome Measures

Prevalence of CBD use (having consumed CBD at least once) [1 day]
The patient will complete a questionnaire about CBD use

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

admitted to the frailty clinic, in Toulouse University Hospital during the recruitment period.

Exclusion Criteria:

major cognitive disorder with Mini Mental State Examination <20
being under legal supervision or guardianship.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Sandrine SOURDET, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT06094582

Other Study ID Numbers:

RC31/23/0494
2023-A02080-45

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

older adults

cannabidiol use

frailty

Additional relevant MeSH terms:

Frailty

Study Results

No Results Posted as of Oct 23, 2023