Purpose

The investigators hypothesize that opioid use in African-Americans will be associated with hypodopaminergic alleles that alter the threshold for activating feelings of reward and pleasure within the dopaminergic system, and that these allelic frequencies will differ significantly from European Americans. Planned is a targeted system to study genetic risks for reward deficiency using risk gene panel to assign a genetic addiction risk score (GARS), comprehensive surveys to determine quality of life and exposure to stressors and trauma. This system will allow prediction of addiction and relapse potential and delivery of personalized treatment.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Must be able to consent and understand questions being asked during surveys - Must be willing to undergo pharmacogenetic testing - Must be able to swallow tablets

Exclusion Criteria

  • Clinical Diagnosis of Alzheimer's disease/Dementia - Clinical Diagnosis of Schizophrenia - Clinical Diagnosis of a terminal disorder

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nutraceutical, KB220Z
A nutraceutical pill containing pro-dopamine precursors
  • Dietary Supplement: KB220Z
    Acts to enhance dopamine
    Other names:
    • KB220
    • Synaptamine
Placebo Comparator
Placebo
A placebo that looks the same and is in a similar bottle
  • Dietary Supplement: Placebo
    A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical

Recruiting Locations

Howard University
Washington, District of Columbia 20059
Contact:
Marjorie C. Gondré-Lewis, PhD
202-806-5274
mgondre-lewis@Howard.edu

More Details

Status
Unknown status
Sponsor
Howard University

Study Contact

Marjorie C. Gondré-Lewis, Ph.D.
202-806-5274
mgondre-lewis@Howard.edu

Detailed Description

Individuals seeking treatment for Opioid Use Disorder in the Washington DC metro area will be recruited to this Study, which consists of 1) early pre-disposition diagnosis using the Genetic Addiction Risk Score (GARS); 2) Assessment of reward deficiency, co-morbid neuropsychiatric disease, quality of life/happiness, stressors/trauma and other psychometric measurements using validated questionnaires; Urine drug testing during actual treatment that uses comprehensive analysis of reported drugs to determine compliance with prescription medications and non-abstinence to illicit drugs; and 4) adjunctive treatment with neuroadaptogen amino acid therapy (NAAT), a glutaminergic-dopaminergic optimization nutraceutical (generic name: KB220) compared to placebo, aimed to prevent relapse by induction of dopamine homeostasis.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.