Evaluation of the efficacy of a mobile application developed for cannabis users to help them reduce or quit their consumption
| ISRCTN | ISRCTN24288134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24288134 |
- Submission date
- 03/10/2024
- Registration date
- 25/11/2024
- Last edited
- 05/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aim
Digital interventions offer opportunities for cannabis users willing to stop or reduce their consumption, but who may be reluctant to seek physical help or are far from a specialised health centre. A personalised 5-week e-coaching program has been designed and developed based on an app in association with other services such as helpline, peer forums and chat services. The main aim of this study is to assess the effectiveness of the cannabis app in helping to stop or reduce cannabis use.
Who can participate?
People aged 18 years or over who are willing to stop or reduce their current cannabis consumption
What does the study involve?
Participants are recruited mainly through the drogues-info-service.fr (DIS) website managed by Santé publique France and randomly allocated to an intervention group or a control group. The intervention group are invited to download the app (available on Google Play and Apple Store). The control group will receive a leaflet with basic information about the harmful effects of cannabis and how to find help. Data will be collected using online questionnaires sent to participants at the start of the study, after the intervention and 3 months later.
To evaluate the effectiveness of the intervention, the number of joints smoked in the last 7 days are compared between the two groups at 3 months after the end of the intervention. Secondly, the number of joints smoked in the last 7 days just after the intervention and the number of days with cannabis consumption in the last 7 days at 3 months will also be compared. The level of satisfaction and perceived utility of the app will also be analysed.
What are the possible benefits and risks of participating?
Participants of the intervention group can continue to use the app beyond the duration of the experiment. Participants in the control group can download the app after answering the last follow-up questionnaire. Participants who have fully completed the three study questionnaires will receive a gift card worth €20 and access to a random draw allowing five of them to win an additional gift card worth €300.
Where is the study run from?
Santé publique France, the French national public health agency, manages the study. As the experiment involves only the use of a personal smartphone, there is no special or dedicated place to participate.
When is the study starting and how long is it expected to run for?
March 2022 to January 2026
Who is funding the study?
Santé publique France
Who is the main contact?
Emmanuel Lahaie, emmanuel.lahaie@santepubliquefrance.fr
Contact information
Public, Scientific, Principal Investigator
Santé publique France
12, rue du val d'osne
Saint Maurice
94415
France
 ORCID ID |
0009-0007-7504-0241 |
|---|---|
| Phone | +33 (0)1 41 79 69 13 |
| emmanuel.lahaie@santepubliquefrance.fr |
Study information
| Study design | Interventional two-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | 46164 PIS.pdf |
| Scientific title | Efficacy of a digital intervention to reduce or stop cannabis use: study protocol for a randomized controlled trial (ESCAL) |
| Study acronym | ESCAL-protocol |
| Study objectives | This mobile application increase the chance of reducing or quiting the cannabis use of cannabis users willing to reduce or quit their consumption |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | In view of the information collected and the type of intervention, this study has been qualified as an evaluation in the field of health outside research involving humans, in accordance with the recommendations of the referal methodology MR-004 of the CNIL (independent administrative authority created by the National Data Protection Act in 1978) As a research of public interest, the data controller has undertaken to collect only data that is strictly necessary and relevant to the objectives of the research. The protocol has been registered in a public directory held by the Health Data Hub (health-data-hub.fr, number 17990932) |
| Health condition(s) or problem(s) studied | Problematic cannabis use |
| Intervention | Cannabis users are invited to complete an online information and consent questionnaire and for those eligible a first questionnaire about their use (T0). Those who have completed the T0 questionnaire are included and randomised into two groups. Randomization follows the order of arrival of participants. Allocation is done every other time in each group. Participants in the intervention group receive: 1. An invitation (email) to download the app, named "Jeanne" and to use it during the 5-week program of the app 2. Invitations to complete two follow-up questionnaires at the end of the program (T1) and 3 months after (T2) Participants in the control (non-intervention) group receive : 1. A PDF leaflet including basic information about the risks of cannabis use 2. Invitations to complete two follow-up questionnaires at T1 and 3 months after (T2) |
| Intervention type | Behavioural |
| Primary outcome measure | The number of joints smoked in the last 7 days, measured at 3 months after the end of the intervention (T2) |
| Secondary outcome measures | 1. The number of joints smoked in the last 7 days, measured just after the intervention (T1) 2. The number of days with cannabis consumption in the last 7 days, measured at 3 months (T2) 3. The level of satisfaction and perceived utility of the app, measured at T1 |
| Overall study start date | 12/03/2022 |
| Completion date | 15/01/2026 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 580 |
| Total final enrolment | 629 |
| Key inclusion criteria | 1. Age >= 18 years old 2. Have used cannabis in the last 7 days 3. Willing to reduce or quit cannabis use in the next 15 days 4. Have a smartphone connected to the internet 5. French speaking |
| Key exclusion criteria | 1. Not currently following treatment for cannabis addiction 2. Not pregnant 3. Not recently hospitalized for mental disorders 4. Not having used digital or online help to stop or reduce cannabis in the last few months |
| Date of first enrolment | 17/10/2024 |
| Date of final enrolment | 31/08/2025 |
Locations
Countries of recruitment
- France
- French Guiana
- French Polynesia
- French Southern Territories
- Saint Martin (French part)
Study participating centre
Saint-Maurice
94415
France
Sponsor information
Government
12, rue du Val d'Osne
Saint-Maurice
94415
France
| Phone | +33 (0)1 41 79 67 00 |
|---|---|
| dpps-raf@santepubliquefrance.fr | |
| Website | http://www.santepubliquefrance.fr/ |
"ROR" |
https://ror.org/00dfw9p58 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an English-language peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Emmanuel Lahaie (emmanuel.lahaie@santepubliquefrance.fr). Anonymized data can be shared with external teams after analysis of the project by Santé publique France and the signing of a confidentiality commitment |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Data collection protocol | 11/10/2024 | No | No | |
| Participant information sheet | 11/10/2024 | No | Yes |
Additional files
- 46164 PIS.pdf
- 46164 data collection protocol.pdf
- Data collection protocol
Editorial Notes
05/09/2025: The following changes were made to the trial record:
1. The completion date was changed from 30/10/2025 to 15/01/2026.
2. The total final enrolment was added.
28/07/2025: The date of final enrolment was changed from 31/07/2025 to 31/08/2025.
21/05/2025: The recruitment end date was changed from 17/05/2025 to 31/07/2025.
08/10/2024: Trial's existence confirmed by Health Data Hub.
