Sports Betting PlayersOSENCT04802226
Optimization of the Self-exclusion Procedure
A study testing self exclusion procedure in people with Sports Betting Players, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
It has been shown that self-excluded gamblers are very heavy gamblers, and that it is not possible to distinguish between those who report self-exclusion for addictive reasons and those who self-exclude for commercial reasons, which strongly suggests that all self-excluded people are "self-diagnosed" problem gamblers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sports Betting Players
- What is being tested?
- self exclusion procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,554 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2021to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Must be self-exclude for the first time
- Must be Online sports betting player
- Must be self-exclusion of 3 months or less (minimum 3 days)
Who cannot join
- Player who has objected to the use of his collected data.
Trial locations and contacts
1 site in 1 country.
About this study
It has been shown that self-excluded gamblers are very heavy gamblers, and that it is not possible to distinguish between those who report self-exclusion for addictive reasons and those who self-exclude for commercial reasons, which strongly suggests that all self-excluded people are "self-diagnosed" problem gamblers. Several studies converge in recognizing self-excluded people as problem gamblers who have lost control of their gambling and are seeking to protect themselves by taking action, self-exclusion, to change their behaviour and protect themselves.
Several reviews of the literature on interventions for problem gamblers have recently identified self-exclusion as an intervention for problem gamblers.
Read more
However, the effectiveness of the current self-exclusion system appears to be limited, particularly for short self-exclusions and for heavier gamblers.
Considering that self-exclusion is an intervention for and by people who have developed a gambling disorder, it currently consists exclusively of a behavioural intervention, in the sense that it prevents the behaviour. It would then be possible to optimize this intervention by enriching it with other components that have been shown to be effective with problem gamblers or in other addictions: a brief intervention including a motivational, cognitive approach, personalized normative feedback, referral to online help services (cresus and gambling infoservice), and repeated contact to suggest an extension of the self-exclusion period without having to return to the gambling environment. We hypothesize improved efficacy as measured by reduced gambling for longer after an initial optimized self-exclusion compared to self-exclusion with the standard procedure. Days will be randomized according to an a priori randomization list, not players.
Read the detailed description
Main Objective:
The primary objective of the study is to evaluate the effect of the optimized self-exclusion procedure, compared to the existing procedure, on the intensity of gambling.
- Primary endpoint The primary endpoint is the change in total net loss over the last 4 weeks, between the last 4 weeks prior to self-exclusion T0, and the last 4 weeks at 12 months T2.
2.2 Secondary objectives The secondary objectives of the study are to assess early effect at 6 months and maintenance of effect at 18 months.
- Secondary endpoints:
The secondary objectives of the study are to evaluate early efficacy at 6 months and maintenance of efficacy at 18 months. The endpoint used is the change in total net loss over the last 4 weeks, between the last 4 weeks prior to self-exclusion, and the last 4 weeks at 6 T1 and 18 months T3. The other criteria will be the change between T0 and T1,2, and 3 of the following variables (total of the last 4 weeks unless otherwise specified):
- Total deposit
- Total bet per game
- Compulsiveness (as defined by three consecutive deposits in a 12-hour period) (yes/no) (number of episodes)
- Maximum number of deposits within one hour of a bet,
- Total loss per game (average)
- Number of gambling sessions (all games) in a clinical sense; session is defined as the gambling behavior itself; we will consider the beginning of a session when a gambling action occurs after no gambling action has occurred for at least 30 minutes, and the end of the gambling session a gambling action followed by no gambling action for 30 minutes.
- Session duration (average)
- Total playing time defined as the sum of the session durations
- Extension of self-exclusion (yes no)
- Second and subsequent self-exclusion (yes no, number)
- Exceeding 80% moderators (sum).
- Conditions
- Sports Betting Players
- Being tested
- self exclusion procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self exclusion procedureOther
self exclusion procedure( responsible gambling tool)
| Study group | Role | What they receive |
|---|---|---|
| optimized self-exclusion procedure A | Experimental | optimized self-exclusion procedure including content optimization with brief intervention, normative feedback, motivational approach, a personal story of a peer who had a positive experience using the tool, re-contact before the end of the self-exclusion period to propose an extension of the period outside the gambling plateform Receives: Other: self exclusion procedure |
| standard self-exclusion B | Other | standard self-exclusion with a single neutral notification email Receives: Other: self exclusion procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in total net loss over the last 4 weeks, between the last 4 weeks prior to self-exclusion T0, and the last 4 weeks at 12 months T2
Measured: between the last 4 weeks before self-exclusion T0, and the last 4 weeks at 12 months T2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start2 Jan 2021
- Primary completion1 May 2024
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Betting PlayersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Naturalistic randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 2,554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802226
- Sponsor's protocol ID
- Local /2020/AL
- Acronym
- OSE
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2021
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Self-exclusion Procedure
- ClinicalTrials.gov ID
- NCT04802226
- Acronym / sponsor ID
- OSE / Local /2020/AL
- Conditions
- Sports Betting Players
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,554 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been shown that self-excluded gamblers are very heavy gamblers, and that it is not possible to distinguish between those who report self-exclusion for addictive reasons and those who self-exclude for commercial reasons, which strongly suggests that all self-excluded people are "self-diagnosed" problem gamblers. Several studies converge in recognizing self-excluded people as problem gamblers who have lost control of their gambling and are seeking to protect themselves by taking action, self-exclusion, to change their behaviour and protect themselves.
Several reviews of the literature on interventions for problem gamblers have recently identified self-exclusion as an intervention for problem gamblers.
However, the effectiveness of the current self-exclusion system appears to be limited, particularly for short self-exclusions and for heavier gamblers.
Considering that self-exclusion is an intervention for and by people who have developed a gambling disorder, it currently consists exclusively of a behavioural intervention, in the sense that it prevents the behaviour. It would then be possible to optimize this intervention by enriching it with other components that have been shown to be effective with problem gamblers or in other addictions: a brief intervention including a motivational, cognitive approach, personalized normative feedback, referral to online help services (cresus and gambling infoservice), and repeated contact to suggest an extension of the self-exclusion period without having to return to the gambling environment. We hypothesize improved efficacy as measured by reduced gambling for longer after an initial optimized self-exclusion compared to self-exclusion with the standard procedure. Days will be randomized according to an a priori randomization list, not players.
Detailed description
Main Objective:
The primary objective of the study is to evaluate the effect of the optimized self-exclusion procedure, compared to the existing procedure, on the intensity of gambling.
- Primary endpoint The primary endpoint is the change in total net loss over the last 4 weeks, between the last 4 weeks prior to self-exclusion T0, and the last 4 weeks at 12 months T2.
2.2 Secondary objectives The secondary objectives of the study are to assess early effect at 6 months and maintenance of effect at 18 months.
- Secondary endpoints:
The secondary objectives of the study are to evaluate early efficacy at 6 months and maintenance of efficacy at 18 months. The endpoint used is the change in total net loss over the last 4 weeks, between the last 4 weeks prior to self-exclusion, and the last 4 weeks at 6 T1 and 18 months T3. The other criteria will be the change between T0 and T1,2, and 3 of the following variables (total of the last 4 weeks unless otherwise specified):
- Total deposit
- Total bet per game
- Compulsiveness (as defined by three consecutive deposits in a 12-hour period) (yes/no) (number of episodes)
- Maximum number of deposits within one hour of a bet,
- Total loss per game (average)
- Number of gambling sessions (all games) in a clinical sense; session is defined as the gambling behavior itself; we will consider the beginning of a session when a gambling action occurs after no gambling action has occurred for at least 30 minutes, and the end of the gambling session a gambling action followed by no gambling action for 30 minutes.
- Session duration (average)
- Total playing time defined as the sum of the session durations
- Extension of self-exclusion (yes no)
- Second and subsequent self-exclusion (yes no, number)
- Exceeding 80% moderators (sum).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Naturalistic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| optimized self-exclusion procedure A | Experimental | Other: self exclusion procedureoptimized self-exclusion procedure including content optimization with brief intervention, normative feedback, motivational approach, a personal story of a peer who had a positive experience using the tool, re-contact before the end of the self-exclusion period to propose an extension of the period outside the gambling plateform |
| standard self-exclusion B | Other | Other: self exclusion procedurestandard self-exclusion with a single neutral notification email |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Must be self-exclude for the first time
- Must be Online sports betting player
- Must be self-exclusion of 3 months or less (minimum 3 days)
Key exclusion criteria (1 listed)
- Player who has objected to the use of his collected data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self exclusion procedureself exclusion procedure( responsible gambling tool) | Other | optimized self-exclusion procedure A, standard self-exclusion B |
Primary outcome
change in total net loss over the last 4 weeks, between the last 4 weeks prior to self-exclusion T0, and the last 4 weeks at 12 months T2
Time frame: between the last 4 weeks before self-exclusion T0, and the last 4 weeks at 12 months T2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self exclusion procedure in people with Sports Betting Players, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in total net loss over the last 4 weeks, between the last 4 weeks prior to self-exclusion T0, and the last 4 weeks at 12 months T2 (time frame: between the last 4 weeks before self-exclusion T0, and the last 4 weeks at 12 months T2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.