NCT04648007

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 23, 2020

Last Update Submit

November 23, 2020

Conditions

Gambling Addiction

Keywords

addictionBDNF

Outcome Measures

Primary Outcomes (1)

  • Assessment of Kaihani Score

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

    1 Week

Study Arms (3)

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

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

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

Interventions

Kaihani ScoreDIAGNOSTIC_TEST

Assessment of neuromodulatory chemicals in peripheral blood plasma samples.

ControlModerate GamblersSevere Gamblers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therapeutic Solutions International

Oceanside, California, 92056, United States

RECRUITING

MeSH Terms

Conditions

GamblingBehavior, Addictive

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersCompulsive BehaviorImpulsive Behavior

Study Officials

  • James Veltmeyer, MD

    Therapeutic Solutions International

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wais Kaihani

CONTACT

619 909 2454waiskaihani@gmail.com

Thomas Ichim, PhD

CONTACT

858 353 4303thomas.ichim@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

December 15, 2020

Primary Completion

March 15, 2021

Study Completion

March 30, 2021

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations

US(1)