EffectS of CAnnabidiol in Patients: Evaluation (ESCAPE)

September 21, 2021 updated by: Nantes University Hospital

Observational Study of Cannabidiol Use in Patients Consulting in Addictology and/ or Algology Departments

Since its recent marketizing in France, the cannabidiol (CBD), a major component of cannabis, is used in many over-the-counter products in France. Some painful patients or patients suffering from addiction seem to use the CBD in search of therapeutic effects. Yet, there are no data available for patients in algology and addictology, particularly with regard to the prevalence of the use of CBD, the effects sought and felt. Faced with the emergence of the use of a substance with a therapeutic purpose but outside a medical framework and without monitoring of adverse effects, it becomes essential to characterize the use of CBD. The main objective of the study is therefore to assess the prevalence of CBD users in algology and addictology departments. Secondary objectives are to characterize the use of CBD as well as the users of CBD, and to evaluate the impact of the use of CBD on other psychoactive substances use or current drug treatments and the drug liking of CBD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Physicians from algology and addictology departments will propose the study to all patients who meet the inclusion criteria during a medical consultation (in hospitalization or ambulatory care). If the patient agrees to participate, the non-opposition will be collected and the physician will complete a short form with sociodemographic data, medical history and contact details of the patient.

The form will be transmitted securely to the research staff that will perform a unique research evaluation face to face (when the patient is still hospitalized and available) or by phone (when the patient is not available during hospitalization or no longer hospitalized or in case of ambulatory care). The research evaluation includes data about the frequency and the duration of the use of all substances (CBD included) in the last 12 months and the frequency of current drug treatments. For patients with CBD use in the last 12 months, additional data regarding the use of CBD will be collected: the form, the route of administration, the effects sought and felt, the method of obtaining, the impact on other drugs and/or substances use and the drug liking of CBD.

A descriptive analysis will be carried out. The CBD user group and the CBD non-user group will be compared on all the variables collected. A multivariate analysis will be carried out in order to identify factors associated to CBD use in algology and addictology patients.

Study Type

Observational

Enrollment (Actual)

746

Contacts and Locations

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

Study Locations

  • France
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Nantes university hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Physicians from algology and addictology departments will propose the study to all patients who meet the inclusion criteria during a medical consultation (in hospitalization or ambulatory care)

Description

Inclusion Criteria:

  • Minimum age of 18 years
  • Patients for whom hospital specialists in algology or addictology have been requested (for hospitalized or ambulatory cares) during the inclusion period.
  • Giving oral non opposition to participate.

Exclusion Criteria:

  • Adults under guardianship or curator
  • Patients unable to respond to the research evaluation (cerebral function disorder, difficulty to understand, read or write French language).

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 users
Time Frame: through study completion, an average of 2 year
For all patients included in the study, the use of CBD during the last 12 months (yes or no) will be collected.
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of the use of CBD
Time Frame: through study completion, an average of 2 year
Prevalence of form, all effects sought and felt, method of obtaining and route of administration of CBD, frequency and duration of the use.
through study completion, an average of 2 year
Characterization of CBD users
Time Frame: through study completion, an average of 2 year
Prevalence of CBD users (use of CBD in the last 12 months) according to patients' characteristics: age categories, sex, employment status, medical history, other psychoactive substances use, current drug treatments.
through study completion, an average of 2 year
Impact of the use of CBD
Time Frame: through study completion, an average of 2 year
Proportion of CBD users who stopped, decreased, increased or initiated drug treatments in relation to the CBD use.
through study completion, an average of 2 year
CBD drug-liking
Time Frame: through study completion, an average of 2 year
Mean on Visual Analog Scale (VAS) on drug liking for CBD and frequency of substances or drug treatments that would be taken as alternatives in the absence of CBD
through study completion, an average of 2 year

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

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)

May 6, 2020

Primary Completion (Actual)

July 26, 2021

Study Completion (Actual)

July 26, 2021

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC19_0405

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.

Clinical Trials on Substance-Related Disorders

Clinical Trials on Form

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe