Substance-Related Disorders Clinical Trial
— ESCAPEOfficial title:
Observational Study of Cannabidiol Use in Patients Consulting in Addictology and/ or Algology Departments
NCT number | NCT04405414 |
Other study ID # | RC19_0405 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 6, 2020 |
Est. completion date | July 26, 2021 |
Verified date | September 2021 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 746 |
Est. completion date | July 26, 2021 |
Est. primary completion date | July 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
France | Nantes University Hospital | Nantes | Loire-Atlantique |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | through study completion, an average of 2 year | |
Secondary | 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. | through study completion, an average of 2 year | |
Secondary | Impact of the use of CBD | 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 | |
Secondary | 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 | through study completion, an average of 2 year |
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