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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06094582
Other study ID # RC31/23/0494
Secondary ID 2023-A02080-45
Status Recruiting
Phase
First received
Last updated
Start date October 26, 2023
Est. completion date May 2024

Study information

Verified date April 2024
Source University Hospital, Toulouse
Contact Sandrine SOURDET, MD
Phone 05 61 77 79 29
Email sourdet.s@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 120 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
Participants will have to fulfill a short questionnaire (10 minutes) concerning their use and knowledges about CBD.

Locations

Country Name City State
France University Hospital Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of CBD use (having consumed CBD at least once) The patient will complete a questionnaire about CBD use 1 day
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