NCT04405414

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
746

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

May 15, 2020

Last Update Submit

September 21, 2021

Conditions

Keywords

Cannabidiolprevalenceepidemiologypainsubstance-related disorders

Outcome Measures

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.

    through study completion, an average of 2 year

Secondary Outcomes (4)

  • Characterization of the use of CBD

    through study completion, an average of 2 year

  • Characterization of CBD users

    through study completion, an average of 2 year

  • Impact of the use of CBD

    through study completion, an average of 2 year

  • CBD drug-liking

    through study completion, an average of 2 year

Interventions

FormOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Minimum age of 18 years
  • Giving oral non opposition to participate.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

MeSH Terms

Conditions

Substance-Related DisordersPain

Interventions

Metabolism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 28, 2020

Study Start

May 6, 2020

Primary Completion

July 26, 2021

Study Completion

July 26, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Locations