Substance-Related DisordersESCAPENCT04405414
EffectS of CAnnabidiol in Patients: Evaluation
An observational study of Substance-Related Disorders, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Form
- How many people
- 746 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2020to 26 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- Adults under guardianship or curator
- Patients unable to respond to the research evaluation (cerebral function disorder, difficulty to understand, read or write French language).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Substance-Related Disorders
- Being tested
- Form
- Keywords
- Cannabidiol, prevalence, epidemiology, pain, substance-related disorders
- Medical subject headings
- Substance-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 year
Secondary outcomes (4)
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.
Measured: through study completion, an average of 2 year
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.
Measured: through study completion, an average of 2 year
Impact of the use of CBD
Proportion of CBD users who stopped, decreased, increased or initiated drug treatments in relation to the CBD use.
Measured: through study completion, an average of 2 year
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
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start6 May 2020
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405414
- Sponsor's protocol ID
- RC19_0405
- Acronym
- ESCAPE
- Status last verified
- Sep 2021
- First submitted
- 15 May 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Cannabidiol Use in Patients Consulting in Addictology and/ or Algology Departments
- ClinicalTrials.gov ID
- NCT04405414
- Acronym / sponsor ID
- ESCAPE / RC19_0405
- Conditions
- Substance-Related Disorders
- Keywords
- Cannabidiol, prevalence, epidemiology, pain, substance-related disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Adults under guardianship or curator
- Patients unable to respond to the research evaluation (cerebral function disorder, difficulty to understand, read or write French language).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FormData 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 | Other | – |
Primary outcome
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.
4 secondary outcomes
Characterization of the use of CBD
Time frame: through study completion, an average of 2 year
Characterization of CBD users
Time frame: through study completion, an average of 2 year
Impact of the use of CBD
Time frame: through study completion, an average of 2 year
CBD drug-liking
Time frame: through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
Related trials for Substance-Related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance-Related Disorders, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CBD users (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.