- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05413564
Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations (PASS)
January 21, 2026 updated by: Centre Hospitalier Universitaire de Nīmes
Considering that self-exclusion from gambling on a particular website is an intervention for and by individuals who have developed a gambling disorder, it is currently exclusively a behavioural intervention in the sense that it prevents the behaviour Resumption of commercial solicitations only in the period when gambling is not accessible in the corresponding website , through voluntary self-exclusion (where the gambler prevents himself or herself from gambling), does not appear to be sufficient to prevent relapse.
Early commercial solicitations, in the immediate intercourse after the end of the self-exlcusion period may precipitate relapse in gamblers whose behaviour change is by definition recent, and who have only received a behavioural measure.
The investigators hypothesize an improved efficacy as measured by reduced gambling after a self-exclusion optimized by a period of suspension of commercial solicitations extended to 9 months, compared to self-exclusion with the standard procedure.
Gamblers will be randomized according to an a priori randomization list.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a study evaluating the impact of PMU's implementation of an optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months, the self-exclusion being referred to as a non-medical "responsible gambling" tool, compared to the standard procedure.
The self-excluded gamblers will be randomized according to an a priori randomization list, and will receive either the optimized self-exclusion procedure A or the standard self-exclusion procedure B. The study consists of a comparison between two groups A and B. The study involves non-medical gambling and socio-demographic data, routinely recorded in a regulatory manner with a permanent CNIL authorization PMU.
Study Type
Interventional
Enrollment (Actual)
2554
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nîmes
-
Nîmes, Nîmes, France, 30029
- Amandine LUQUIENS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years or older
- self-excluder during the recruitment period
- Online sports betting
- poker and horse racing player
- account opened for at least 4 weeks
- self-exclusion for 3 months or less (minimum 3 days).
Exclusion Criteria:
- Player who has objected to the use of his collected data when opening his account.
- It's not the first self-exclusion of the inclusion period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: optimized self-exclusion procedure A
optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months
|
optimized self-exclusion procedure A
|
|
Other: standard procedure
standard self-exclusion procedure B
|
optimized self-exclusion procedure A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in total net loss
Time Frame: over the last 4 weeks,between the last 4 weeks before self-exclusion T0, and the last 4 weeks at 9 months T2
|
Evaluate the effect of the self-exclusion procedure optimized by extending the suspension of commercial solicitations for a total of 9 months, compared to the existing procedure, on the intensity of gambling.
|
over the last 4 weeks,between the last 4 weeks before self-exclusion T0, and the last 4 weeks at 9 months T2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in total net loss
Time Frame: between last 4 weeks prior to self-exclusion, and last 4 weeks at 6 months T1, 12 months T3 and 18 months T4
|
Evaluate early efficacy at 6 months, maintenance of efficacy at 18 months comparison of changes according to type of play
|
between last 4 weeks prior to self-exclusion, and last 4 weeks at 6 months T1, 12 months T3 and 18 months T4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2022
Primary Completion (Actual)
November 1, 2022
Study Completion (Actual)
May 1, 2024
Study Registration Dates
First Submitted
May 24, 2022
First Submitted That Met QC Criteria
June 7, 2022
First Posted (Actual)
June 10, 2022
Study Record Updates
Last Update Posted (Actual)
January 23, 2026
Last Update Submitted That Met QC Criteria
January 21, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL 2021 /AL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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