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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05413564
• Collaborator: (none)
• Enrollment: 2,554
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 70.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gambling Disorder	Other: optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 2554 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations
• Actual Study Start Date: May 30, 2022
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: May 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change in total net loss [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.

Secondary Outcome Measures

1. change in total net loss [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amandine LUQUIENS	Nîmes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT05413564
• Other Study ID Numbers: LOCAL 2021 /AL
• First Posted: Jun 10, 2022
• Last Update Posted: Jun 14, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gambling

Study Results

No Results Posted as of Jun 14, 2022