SMART Brain Health in African-Americans

Not Applicable

• Conditions: Substance Use Disorders; African Americans; Opioid Use Disorder; Dopamine Dysregulation Syndrome
• Interventions: Dietary Supplement: KB220Z; Dietary Supplement: Placebo

• Registration Number: NCT03861832
• Lead Sponsor: Howard University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2018-06-16
• Study First Submitted: 2018-07-16
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-01
• Last Update Submitted: 2019-03-01
• Study First Posted: 2019-03-04
• Last Update Posted: 2019-03-04
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutraceutical, KB220Z	KB220Z	A nutraceutical pill containing pro-dopamine precursors
Placebo	Placebo	A placebo that looks the same and is in a similar bottle

Primary Outcome Measures

Name	Time	Method
Addiction Severity Index (ASI)	4 months	Change in indices associated with addiction and associated behaviors
Drug Relapse	4 months	Number of times opioids and other types of drugs of abuse are detected in urine
Change in assessment of depression, anxiety, PTSD	4 months	Change from Baseline in from the Comprehensive Universal Behavioral Screen for depression, anxiety, PTSD, after 4 months
Change in Reward Deficiency Syndrome Questionnaire (RDSQ)	4 months	Change in risky behaviors
Vitamin B6 testing	Month 4	Presence of B6 in blood to test for compliance with Nutraceutical
Genetic Testing for the number of risk alleles for Reward Genes through GARS	Month 1	Number of reward gene variants in opioid use disorder patients compared to controls

Trial Locations

Locations (2)

Howard University; 🇺🇸 Washington, District of Columbia, United States

Medical Home Development Group; 🇺🇸 Washington, District of Columbia, United States