Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations

Gambling Disorder Clinical Trial

— PASS  

Official title:

Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413564
• Other study ID #: LOCAL 2021 /AL
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Amandine LUQUIENS, MD, PhD
• Phone: 0609566346
• Email: amandine.luquiens[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2554
• Est. completion date: May 31, 2025
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gambling
• Gambling Disorder

Intervention

Other:
• optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months
optimized self-exclusion procedure A

Locations

Country	Name	City	State
France	Amandine LUQUIENS	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in total net loss	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	change in total net loss	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