Gambling DisorderPASSNCT05413564
Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations
A study testing optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months in people with Gambling Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,554 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gambling Disorder
- Being tested
- optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 monthsOther
optimized self-exclusion procedure A
| Study group | Role | What they receive |
|---|---|---|
| optimized self-exclusion procedure A | Other | optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months Receives: Other: optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months |
| standard procedure | Other | standard self-exclusion procedure B Receives: Other: optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over the last 4 weeks,between the last 4 weeks before self-exclusion T0, and the last 4 weeks at 9 months T2
Secondary outcomes (1)
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
Measured: between last 4 weeks prior to self-exclusion, and last 4 weeks at 6 months T1, 12 months T3 and 18 months T4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start30 May 2022
- Primary completion1 Nov 2022
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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
- NCT05413564
- Sponsor's protocol ID
- LOCAL 2021 /AL
- Acronym
- PASS
- Status last verified
- Jan 2026
- First submitted
- 24 May 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
von Hammerstein C, Benyamina A, Luquiens A. Long-term efficacy of an optimized online gambling self-exclusion procedure with extended suspension of commercial solicitations: a randomized controlled trial. Harm Reduct J. 2025 Dec 30;22(1):204. doi: 10.1186/s12954-025-01339-0.
PubMed 41469674
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations
- ClinicalTrials.gov ID
- NCT05413564
- Acronym / sponsor ID
- PASS / LOCAL 2021 /AL
- Conditions
- Gambling Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,554 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 10 Jun 2022 (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.
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.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| optimized self-exclusion procedure A | Other | Other: optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 monthsoptimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months |
| standard procedure | Other | Other: optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 monthsstandard self-exclusion procedure B |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 monthsoptimized self-exclusion procedure A | Other | optimized self-exclusion procedure A, standard procedure |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 41469674von Hammerstein C, Benyamina A, Luquiens A. Long-term efficacy of an optimized online gambling self-exclusion procedure with extended suspension of commercial solicitations: a randomized controlled trial. Harm Reduct J. 2025 Dec 30;22(1):204. doi: 10.1186/s12954-025-01339-0.
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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 optimized self-exclusion procedure by extending the suspension of commercial solicitations for a total of 9 months in people with Gambling Disorder, 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413564, which also lists 1 linked publication.
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 23 Jan 2026.