Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
30 participants
OBSERVATIONAL
2020-12-15
2021-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
Kaihani Score
Assessment of neuromodulatory chemicals in peripheral blood plasma samples.
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).
Kaihani Score
Assessment of neuromodulatory chemicals in peripheral blood plasma samples.
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).
Kaihani Score
Assessment of neuromodulatory chemicals in peripheral blood plasma samples.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Kaihani Score
Assessment of neuromodulatory chemicals in peripheral blood plasma samples.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* First-time consultants.
* Without psychotropic treatment or treatment with a stable and unchanged for over a month.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Therapeutic Solutions International
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Veltmeyer, MD
Role: PRINCIPAL_INVESTIGATOR
Therapeutic Solutions International
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Therapeutic Solutions International
Oceanside, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Wais Kaihani
Role: primary
Thomas Ichim
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TSOI-003
Identifier Type: -
Identifier Source: org_study_id