Validation of Kaihani Score for Gambling Addiction

• ClinicalTrials.gov Identifier: NCT04648007
• Recruitment Status: Unknown
• First Posted: December 1, 2020
• Last Update Posted: December 1, 2020
• Sponsor: Therapeutic Solutions International
• Information provided by (Responsible Party): Therapeutic Solutions International

Tracking Information

• First Submitted Date: November 23, 2020
• First Posted Date: December 1, 2020
• Last Update Posted Date: December 1, 2020
• Estimated Study Start Date: December 15, 2020
• Estimated Primary Completion Date: March 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 23, 2020)

Assessment of Kaihani Score [ Time Frame: 1 Week ]

Kaihani Score will be compared between non-gamblers, moderate gamblers, and severe gamblers.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Validation of Kaihani Score for Gambling Addiction
• Official Title: Diagnostic Ability of Plasma Based Neuromodulatory Cytokine Production (Kaihani Score) in Gambling Addiction

Brief 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 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: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• 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.
• Condition: Gambling Addiction

Intervention

Diagnostic Test: Kaihani Score

Assessment of neuromodulatory chemicals in peripheral blood plasma samples.

Study Groups/Cohorts

• 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).
  Intervention: 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).
  Intervention: 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).
  Intervention: Diagnostic Test: Kaihani Score

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 23, 2020): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 30, 2021
• Estimated Primary Completion Date: March 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04648007
• Other Study ID Numbers: TSOI-003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Therapeutic Solutions International
• Original Responsible Party: Same as current
• Current Study Sponsor: Therapeutic Solutions International
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: James Veltmeyer, MD; Therapeutic Solutions International

• PRS Account: Therapeutic Solutions International
• Verification Date: November 2020