Validation of Kaihani Score for Gambling Addiction

Gambling Addiction Clinical Trial

Official title:

Diagnostic Ability of Plasma Based Neuromodulatory Cytokine Production (Kaihani Score) in Gambling Addiction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648007
• Other study ID #: TSOI-003
• Status: Recruiting
• Start date: December 15, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: November 2020
• Source: Therapeutic Solutions International
• Contact: Wais Kaihani
• Phone: 619 909 2454
• Email: waiskaihani[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2021
• Est. primary completion date: March 15, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Gambling
• Gambling Addiction

Intervention

Diagnostic Test:
• Kaihani Score
Assessment of neuromodulatory chemicals in peripheral blood plasma samples.

Locations

Country	Name	City	State
United States	Therapeutic Solutions International	Oceanside	California

Sponsors (1)

Lead Sponsor	Collaborator
Therapeutic Solutions International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Kaihani Score	Kaihani Score will be compared between non-gamblers, moderate gamblers, and severe gamblers.	1 Week