Trial | NCT03861832  Report issue

Title

SMART Brain Health in African-Americans
A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    KB220Z ...

  • Study Participants

    140
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.
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.
Study Started
Jun 16
2018
Primary Completion
Aug 30
2019
Anticipated
Study Completion
Aug 30
2019
Anticipated
Last Update
Mar 04
2019

Dietary Supplement KB220Z

Acts to enhance dopamine

  • Other names: KB220, Synaptamine

Dietary Supplement Placebo

A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical

Nutraceutical, KB220Z Experimental

A nutraceutical pill containing pro-dopamine precursors

Placebo Placebo Comparator

A placebo that looks the same and is in a similar bottle

Criteria 

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
No Results Posted