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

NCT05633043 | Unknown

• 1 other identifier: RNI 2021 LAPORTE
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 5

Brief 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. 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. 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.

Conditions

Cannabis; Addictive Behavior; General Practice; Primary Care; Substance-Related Disorders; Questionnaires

Outcome Measures

Primary Outcomes (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).

  12 months

Study Arms (6)

16-18 year, CAST binary version

Enrollment 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 version

Enrollment 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 version

Enrollment 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 version

Enrollment 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 version

Enrollment 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 version

Enrollment 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.

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (5)

Département de Médecine Générale de Clermont-Ferrand

Clermont-Ferrand, France

Location

Département de Médecine Générale de Grenoble

Grenoble, France

Location

Département Universitaire de Médecine Générale, Lyon

Lyon, France

Location

Département de Médecine Générale de Saint-Etienne

Saint-Etienne, France

Location

Département Universitaire de Médecine Générale, Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Marijuana Abuse; Behavior, Addictive; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Central Study Contacts

Lise Laclautre

CONTACT

04 73 75 11 95; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)