Knowledges and Use of Cannabidiol in Older Adults (CBD-65)

April 29, 2024 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31059
        • Recruiting
        • University Hospital Toulouse
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

older adults

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of CBD use (having consumed CBD at least once)
Time Frame: 1 day
The patient will complete a questionnaire about CBD use
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Estimated)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0494
  • 2023-A02080-45 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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