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CannabisGP-CASTNCT05633043

Validation of the Cannabis Abuse Screening Test in General Practice(GP-CAST)

An observational study of Cannabis and Addictive Behavior, run by University Hospital, Clermont-Ferrand at 5 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In France, consumption levels of alcohol, tobacco and cannabis remain high despite changes in regulations aimed at limiting access to these products and repeated prevention campaigns. Read more about this study

Who is it for?
Ages 16 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis, Addictive Behavior, General Practice
How many people
660 participants
Where
5 sitesFrance
Study dates
1 Jan 2023to 1 Jun 2024
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 16 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Test phase: Patients will be recruited from the active file of general practitioners participating in the study and according to the specified inclusion criteria. An information letter outlining the objectives of the study will be given to the patients and the physician will inform them that the data will be anonymized and will remain strictly confidential. The patient will be informed that his or her decision to participate in the study or not will not affect his or her treatment. The patient will also be informed of his or her right to withdraw from the study at any time without justification and without consequence on his or her care. Retest phase: The patient must return the completed CAST scale (in the same format as the one submitted during the inclusion consultation) within a maximum of 2 to 4 weeks by mail to the coordinating center in a pre-stamped envelope provided. He/she will receive financial compensation upon receipt of the Retest questionnaire.

Who may be able to join

  • Patients aged 16 to 45 years, Patients with cannabis use in the last 12 months, Patients followed in general medicine, Patients able to give free and informed consent to participate in the research, Patients affiliated to the French Social Security.

Who cannot join

  • Patients who started using cannabis less than 12 months ago, Stop using cannabis on the day of the test phase (no Retest phase possible), Patients in the process of withdrawal (risk of being withdrawn during the Retest phase), Patients undergoing treatment in an addiction care and prevention center (CSAPA), Patients with decompensated psychosis, Patients unable to complete the questionnaire on their own or with difficulties in understanding the French language, Patients refusing to participate in the research.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites
  • Département de Médecine Générale de Clermont-Ferrand

    Clermont-Ferrand

    Lise Laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr

    Catherine LAPORTE

  • Département de Médecine Générale de Grenoble

    Grenoble

    Yoann GABOREAU

  • Département Universitaire de Médecine Générale, Lyon

    Lyon

  • Département de Médecine Générale de Saint-Etienne

    Saint-Etienne

  • Département Universitaire de Médecine Générale, Toulouse

    Toulouse

    Julie DUPOUY

Other trials in France

About this study

In France, consumption levels of alcohol, tobacco and cannabis remain high despite changes in regulations aimed at limiting access to these products and repeated prevention campaigns. The various Presidential Plans for the treatment and prevention of addictions for 2007-2011 and 2018-2022 show the concern of the public authorities on the issue of multiple consumption, encouraging general practitioners to identify and research this issue.

In order to better identify and evaluate high-risk cannabis use, the French Observatory for Drugs and Drug Addiction has developed a detection tool: The Cannabis Abuse Screening Test (CAST). Although recommended in France, this questionnaire has never been tested in real primary care conditions, directly with patients consulting general medicine.

Read more

The main objective of this study is the validation of a scale for the identification of problematic cannabis use, CAST, with a response modality according to a Likert scale (rated from 0 to 4 : 0 "never", 1 "rarely", 2 "occasionally", 3 "quite often", 4 "very often") or a binary response modality (response by 1 "Yes" or 0 "No") in patients who have used cannabis in the past 12 months, followed in general practice and in 3 age categories (15-18 years, 18-25 years and 25-45 years). The secondary objective is to analyze the polydrug use of alcohol and tobacco, and then the relationship between them and the level of cannabis use.

This validation study of diagnostic scales in real-life situations with general medicine patients allows us to focus on the human and social sciences and public health. Although it has now been established that there is a synergy between several addictive substances with respect to cancer risks, few studies have focused on the early identification of misuse or polydrug use. However, it has been shown that general practitioners (GPs) are effective and relevant players in these fields. Because of their holistic vision of the patient, GPs are in the best position to identify consumers at risk of complications without blaming, dramatizing or trivializing. It is therefore necessary to provide GPs with early detection tools to promote contact between these patients and the healthcare system.

Read the detailed description

Cannabis is the most widely used illicit substance in France. In order to identify and assess problematic use, the OFDT has developed the Cannabis Abuse Screening Test or CAST.

The French National Authority for Health recommends a tool for early identification and brief intervention for alcohol, cannabis and tobacco use in adults. It includes the CAST questionnaire with YES or NO answers to the questions, but it has not been validated in primary care in this modality (only in a Likert format).

General practitioners therefore do not have a validated tool to screen patients with cannabis use disorder. A quick and efficient tool would allow to optimize the screening practices in general practice by adapting the thresholds of results by sex and age groups.

Primary objective and primary outcome Validation of a Cannabis Abuse Screening Test (CAST) risky cannabis use identification scale with a Likert scale response modality (rated from 0 to 4: 0 "never," 1 "rarely," 2 "occasionally," 3 "quite often," 4 "very often") or a binary response modality (response by 1 "YES" or 0 "NO"), in patients who had used cannabis in the past 12 months, followed up in general practice and among 3 age categories (16-18 years, 18-25 years, 25-45 years).

Secondary objectives and outcome measures

  1. To compare the psychometric properties of the CAST according to its 2 response modalities, with respect to their ability to identify early on users with a cannabis use disorder.
  2. To determine consumption patterns by age group and their possible links with problematic cannabis use based on the time frame of first use.
  3. To analyze the polyconsumption of alcohol, tobacco, e-cigarettes and/or other drugs, and the links between them and cannabis use.
  4. To describe patient profiles at risk of cannabis misuse through socio-demographic data, medical data and polyuse.

Schema of the study The objective of this study is to test the CAST questionnaire according to its 2 response modalities, complete and binary. To do this, we will constitute 2 groups of patients: the first will fill in the Cast in binary version (1 "Yes" or 0 "No") and the second will fill in the Likert version. In each of the 2 groups, the 2 versions of the CAST questionnaire will be filled in according to the same procedure: the questionnaire will be filled in by the patient, without any intervention by the physician, at the time of inclusion in general medicine. A questionnaire will be completed 15 days later by the patient at home and returned by mail in a stamped envelope.

Methodology

The following psychometric properties of the CAST scale, in its full and binary versions, will be explored by age categories (16-18 years, 18-25 years, 25-45 years):

  • The measure of questionnaire acceptability;
  • The reliability (or precision) of the instrument will be assessed according to two criteria: internal consistency and test-retest reproducibility;
  • Internal structural validity will explore the consistency of the internal layout of the scale. A factorial analysis approach will complete these analyses;
  • The indicators described above (Cronbach, Kappa, correlation coefficient and optimal thresholds) will be systematically compared between the two versions of the CAST scale under study.

Enrollment The size estimate is based on COSMIN recommendations (https://www.cosmin.nl/) (3). To achieve psychometric validity of the CAST, 110 patients should be included, 50 of whom would be retested. It is proposed to include 110 patients for each of the 3 age categories under study (16-18 years, 18-25 years and 25-45 years) and for each of the 2 scales tested, i.e. a total of 110*3 (age classes)*2 versions of the CAST = 660 patients. In each age category and for each scale: 50 patients (among the 110) will have to complete the Retest phase, i.e. 50*3*2=300 patients (among the 660).

Five inclusion centers (DMG) will participate in the study, which makes 132 patients per investigating center (66 patients for each scale, i.e. 22 patients for each scale and each age category in each DMG). The GPs will have to include 13.2 patients, during the 12 months of the study.

Inclusion criteria Patients aged 16 to 45 years, Patients with cannabis use in the past 12 months, Patients followed in general medicine, Patients able to give free and informed consent to participate in the research, Patients affiliated to the French Social Security.

Non-inclusion criteria Patients who started using cannabis less than 12 months ago, Cessation of cannabis use on the day of the test phase (no Retest phase possible), Patients in the process of withdrawal (risk of being withdrawn during the Retest phase), Patients undergoing treatment in an addiction care and prevention center (CSAPA), Patients with decompensated psychosis, Patients unable to complete the questionnaire on their own or with difficulties in understanding the French language, Patients refusing to participate in the research.

Medical subject headings
Marijuana Abuse, Behavior, Addictive, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05633043
Study groupRoleWhat they receive
16-18 year, CAST binary versionEnrollment estimates are based on COSMIN recommendations (https://www.cosmin.nl/) (3). To achieve psychometric validity of the CAST, 110 patients should be included, 50 of whom would be retested. It is proposed to include 110 patients for each of the 3 age categories under study (16-18 years, 18-25 years and 25-45 years) and for each of the 2 scales tested, i.e. a total of 110*3 (age classes)*2 versions of the CAST = 660 patients. In each age category and for each scale: 50 patients (among the 110) will have to complete the Retest phase, i.e. 50*3*2=300 patients (among the 660). Five inclusion centers (DMG) will participate in the study, which makes 132 patients per investigating center (66 patients for each scale, i.e. 22 patients for each scale and each age category in each DMG). The GPs will have to include 13.2 patients, during the 12 months of the study.
16-18 year, CAST Likert versionEnrollment estimates are based on COSMIN recommendations (https://www.cosmin.nl/) (3). To achieve psychometric validity of the CAST, 110 patients should be included, 50 of whom would be retested. It is proposed to include 110 patients for each of the 3 age categories under study (16-18 years, 18-25 years and 25-45 years) and for each of the 2 scales tested, i.e. a total of 110*3 (age classes)*2 versions of the CAST = 660 patients. In each age category and for each scale: 50 patients (among the 110) will have to complete the Retest phase, i.e. 50*3*2=300 patients (among the 660). Five inclusion centers (DMG) will participate in the study, which makes 132 patients per investigating center (66 patients for each scale, i.e. 22 patients for each scale and each age category in each DMG). The GPs will have to include 13.2 patients, during the 12 months of the study.
18-25 year, CAST binary versionEnrollment estimates are based on COSMIN recommendations (https://www.cosmin.nl/) (3). To achieve psychometric validity of the CAST, 110 patients should be included, 50 of whom would be retested. It is proposed to include 110 patients for each of the 3 age categories under study (16-18 years, 18-25 years and 25-45 years) and for each of the 2 scales tested, i.e. a total of 110*3 (age classes)*2 versions of the CAST = 660 patients. In each age category and for each scale: 50 patients (among the 110) will have to complete the Retest phase, i.e. 50*3*2=300 patients (among the 660). Five inclusion centers (DMG) will participate in the study, which makes 132 patients per investigating center (66 patients for each scale, i.e. 22 patients for each scale and each age category in each DMG). The GPs will have to include 13.2 patients, during the 12 months of the study.
18-25 year, CAST Likert versionEnrollment estimates are based on COSMIN recommendations (https://www.cosmin.nl/) (3). To achieve psychometric validity of the CAST, 110 patients should be included, 50 of whom would be retested. It is proposed to include 110 patients for each of the 3 age categories under study (16-18 years, 18-25 years and 25-45 years) and for each of the 2 scales tested, i.e. a total of 110*3 (age classes)*2 versions of the CAST = 660 patients. In each age category and for each scale: 50 patients (among the 110) will have to complete the Retest phase, i.e. 50*3*2=300 patients (among the 660). Five inclusion centers (DMG) will participate in the study, which makes 132 patients per investigating center (66 patients for each scale, i.e. 22 patients for each scale and each age category in each DMG). The GPs will have to include 13.2 patients, during the 12 months of the study.
25-45 year, CAST binary versionEnrollment estimates are based on COSMIN recommendations (https://www.cosmin.nl/) (3). To achieve psychometric validity of the CAST, 110 patients should be included, 50 of whom would be retested. It is proposed to include 110 patients for each of the 3 age categories under study (16-18 years, 18-25 years and 25-45 years) and for each of the 2 scales tested, i.e. a total of 110*3 (age classes)*2 versions of the CAST = 660 patients. In each age category and for each scale: 50 patients (among the 110) will have to complete the Retest phase, i.e. 50*3*2=300 patients (among the 660). Five inclusion centers (DMG) will participate in the study, which makes 132 patients per investigating center (66 patients for each scale, i.e. 22 patients for each scale and each age category in each DMG). The GPs will have to include 13.2 patients, during the 12 months of the study.
25-45 year, CAST Likert versionEnrollment estimates are based on COSMIN recommendations (https://www.cosmin.nl/) (3). To achieve psychometric validity of the CAST, 110 patients should be included, 50 of whom would be retested. It is proposed to include 110 patients for each of the 3 age categories under study (16-18 years, 18-25 years and 25-45 years) and for each of the 2 scales tested, i.e. a total of 110*3 (age classes)*2 versions of the CAST = 660 patients. In each age category and for each scale: 50 patients (among the 110) will have to complete the Retest phase, i.e. 50*3*2=300 patients (among the 660). Five inclusion centers (DMG) will participate in the study, which makes 132 patients per investigating center (66 patients for each scale, i.e. 22 patients for each scale and each age category in each DMG). The GPs will have to include 13.2 patients, during the 12 months of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validation of a Cannabis Abuse Screening Test (CAST) in general practice

    Validation of a Cannabis Abuse Screening Test (CAST) with a Likert scale response modality (rated from 0 to 4: 0 "never," 1 "rarely," 2 "occasionally," 3 "quite often," 4 "very often") or a binary response modality (response by 1 "YES" or 0 "NO"), in patients who had used cannabis in the past 12 months, followed up in general practice and among 3 age categories (16-18 years, 18-25 years, 25-45 years).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

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
Other
Enrolment
660 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05633043
Sponsor's protocol ID
RNI 2021 LAPORTE
Acronym
GP-CAST
Status last verified
Oct 2022
First submitted
21 Nov 2022
Last updated
1 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cannabis and Addictive Behavior, run by University Hospital, Clermont-Ferrand at 5 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lise Laclautre (04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validation of a Cannabis Abuse Screening Test (CAST) in general practice (time frame: 12 months). 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 1 Dec 2022.

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