Gambling AddictionNCT04648007
Validation of Kaihani Score for Gambling Addiction
An observational study of Gambling Addiction, run by Therapeutic Solutions International at 1 site in United States.
Trial summary
The Kaihani Score is a blood based means of assessing molecules believed to be associated with gambling addiction. The current clinical trial will assess the Kaihani Score in 3 groups: Group 1: 10 patients with no personal or family problems with gambling as assessed by the PG-YBOCS (obsessions-compulsions scale… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gambling Addiction
- What is being tested?
- Kaihani Score
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 30 Mar 2021
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: The study population will comprise of 10 healthy volunteers, as well as 20 patients with gambling addictions. 10 of the patients will have moderate and 10 will have severe gambling addiction.
Who may be able to join
- Patients with a diagnosis of pathological gambling (DSM IV criteria)
- First-time consultants.
- Without psychotropic treatment or treatment with a stable and unchanged for over a month.
Who cannot join
- Pregnant women and patients with hearing disorders
- Epilepsy (untreated or poorly balanced)
- Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
- History of head trauma with loss of consciousness,
- Administration of drugs or substances lowering the seizure threshold
- Sleep deprivation, jet lag, or drug withdrawal.
- Participants with a problem of uncorrected visual acuity.
- Other current addiction.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Therapeutic Solutions International
Oceanside, California, 92056
Wais Kaihani, 619-909-2454, waiskaihani@gmail.com
Thomas Ichim, 8583534303, thomas.ichim@gmail.com
About this study
Official title: Diagnostic Ability of Plasma Based Neuromodulatory Cytokine Production (Kaihani Score) in Gambling Addiction
The Kaihani Score is a blood based means of assessing molecules believed to be associated with gambling addiction.
The current clinical trial will assess the Kaihani Score in 3 groups:
Read more
Group 1: 10 patients with no personal or family problems with gambling as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).
Group 2: 10 patients with moderate gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).
Group 3: 10 patients with severe gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).
The goal of the study is to confirm preliminary efficacy of the Kaihani Score as a blood based means of assessing gambling propensity.
- Conditions
- Gambling Addiction
- Being tested
- Kaihani Score
- Keywords
- addiction, BDNF
- Medical subject headings
- Gambling, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaihani ScoreDiagnostic test
Assessment of neuromodulatory chemicals in peripheral blood plasma samples.
| Study group | Role | What they receive |
|---|---|---|
| Control | 10 patients with no personal or family problems with gambling as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). Receives: Diagnostic Test: Kaihani Score | |
| Moderate Gamblers | 10 patients with moderate gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). Receives: Diagnostic Test: Kaihani Score | |
| Severe Gamblers | 10 patients with severe gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). Receives: Diagnostic Test: Kaihani Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Kaihani Score
Kaihani Score will be compared between non-gamblers, moderate gamblers, and severe gamblers.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start15 Dec 2020 (estimated)
- Primary completion15 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling AddictionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therapeutic Solutions International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Veltmeyer, MD, Principal investigator, Therapeutic Solutions International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648007
- Sponsor's protocol ID
- TSOI-003
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Ability of Plasma Based Neuromodulatory Cytokine Production (Kaihani Score) in Gambling Addiction
- ClinicalTrials.gov ID
- NCT04648007
- Acronym / sponsor ID
- TSOI-003
- Conditions
- Gambling Addiction
- Keywords
- addiction, BDNF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Therapeutic Solutions InternationalIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 15 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 1 Dec 2020 (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.
The Kaihani Score is a blood based means of assessing molecules believed to be associated with gambling addiction.
The current clinical trial will assess the Kaihani Score in 3 groups:
Group 1: 10 patients with no personal or family problems with gambling as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).
Group 2: 10 patients with moderate gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).
Group 3: 10 patients with severe gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS).
The goal of the study is to confirm preliminary efficacy of the Kaihani Score as a blood based means of assessing gambling propensity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Kaihani Score10 patients with no personal or family problems with gambling as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). |
| Moderate Gamblers | – | Diagnostic Test: Kaihani Score10 patients with moderate gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). |
| Severe Gamblers | – | Diagnostic Test: Kaihani Score10 patients with severe gambling addiction as assessed by the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise of 10 healthy volunteers, as well as 20 patients with gambling addictions. 10 of the patients will have moderate and 10 will have severe gambling addiction.
Key inclusion criteria (3 listed)
- Patients with a diagnosis of pathological gambling (DSM IV criteria)
- First-time consultants.
- Without psychotropic treatment or treatment with a stable and unchanged for over a month.
Key exclusion criteria (8 listed)
- Pregnant women and patients with hearing disorders
- Epilepsy (untreated or poorly balanced)
- Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
- History of head trauma with loss of consciousness,
- Administration of drugs or substances lowering the seizure threshold
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 |
|---|---|---|
| Kaihani ScoreAssessment of neuromodulatory chemicals in peripheral blood plasma samples. | Diagnostic test | Control, Moderate Gamblers, Severe Gamblers |
Primary outcome
Assessment of Kaihani Score
Time frame: 1 Week
Kaihani Score will be compared between non-gamblers, moderate gamblers, and severe gamblers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
James Veltmeyer, MD principal investigator
Therapeutic Solutions International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gambling Addiction, run by Therapeutic Solutions International at 1 site in United States.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 1 Dec 2020. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wais Kaihani (619 909 2454, waiskaihani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Kaihani Score (time frame: 1 Week). 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 1 Dec 2020.