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CompletedNCT04405414ESCAPEUpdated Sep 22, 2021

EffectS of CAnnabidiol in Patients: Evaluation

An observational study in Substance-Related Disorders, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-22.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
746
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Substance-Related Disorders

Keywords

  • Cannabidiol
  • prevalence
  • epidemiology
  • pain
  • substance-related disorders
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 746 is above the median of 250 across 296 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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)

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

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).
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
746 participants (actual)
Patient registry
No

Interventions

  • OtherForm

    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

06

What researchers measure

Primary outcomes

  1. Prevalence of CBD users

    For all patients included in the study, the use of CBD during the last 12 months (yes or no) will be collected.

    Time frame: through study completion, an average of 2 year

Secondary outcomes

  1. Characterization of the use of CBD

    Prevalence of form, all effects sought and felt, method of obtaining and route of administration of CBD, frequency and duration of the use.

    Time frame: through study completion, an average of 2 year

  2. Characterization of CBD users

    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.

    Time frame: through study completion, an average of 2 year

  3. Impact of the use of CBD

    Proportion of CBD users who stopped, decreased, increased or initiated drug treatments in relation to the CBD use.

    Time frame: through study completion, an average of 2 year

  4. CBD drug-liking

    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

    Time frame: through study completion, an average of 2 year

07

Study locations

1 site
  • Nantes University Hospital
    Nantes, Loire-Atlantique 44093, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04405414
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
May 28, 2020
Start date
May 6, 2020
Primary completion
Jul 26, 2021
Completion
Jul 26, 2021
Last update
Sep 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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