Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of Kaihani Score for Gambling Addiction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04648007
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Therapeutic Solutions International

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.


Condition or disease Intervention/treatment
Gambling Addiction Diagnostic Test: Kaihani Score

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Diagnostic Ability of Plasma Based Neuromodulatory Cytokine Production (Kaihani Score) in Gambling Addiction
Estimated Study Start Date : December 15, 2020
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Diagnostic Test: 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).
Diagnostic Test: 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).
Diagnostic Test: Kaihani Score
Assessment of neuromodulatory chemicals in peripheral blood plasma samples.




Primary Outcome Measures :
  1. Assessment of Kaihani Score [ Time Frame: 1 Week ]
    Kaihani Score will be compared between non-gamblers, moderate gamblers, and severe gamblers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04648007


Contacts
Layout table for location contacts
Contact: Wais Kaihani 619 909 2454 waiskaihani@gmail.com
Contact: Thomas Ichim, PhD 858 353 4303 thomas.ichim@gmail.com

Locations
Layout table for location information
United States, California
Therapeutic Solutions International Recruiting
Oceanside, California, United States, 92056
Contact: Wais Kaihani    619-909-2454    waiskaihani@gmail.com   
Contact: Thomas Ichim    8583534303    thomas.ichim@gmail.com   
Principal Investigator: James Veltmeyer, MD         
Sponsors and Collaborators
Therapeutic Solutions International
Investigators
Layout table for investigator information
Principal Investigator: James Veltmeyer, MD Therapeutic Solutions International
Layout table for additonal information
Responsible Party: Therapeutic Solutions International
ClinicalTrials.gov Identifier: NCT04648007    
Other Study ID Numbers: TSOI-003
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Therapeutic Solutions International:
addiction
BDNF
Additional relevant MeSH terms:
Layout table for MeSH terms
Behavior, Addictive
Gambling
Compulsive Behavior
Impulsive Behavior
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders