SMART Brain Health in African-Americans

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder

Conditions
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Opioid Use Disorder, Substance Use Disorders, Dopamine Dysregulation Syndrome, African Americans

Intervention / Treatment
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* Dietary Supplement: KB220Z
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutraceutical, KB220Z<br>A nutraceutical pill containing pro-dopamine precursors | Dietary Supplement: KB220Z<br>* Acts to enhance dopamine<br>* Other names: Synaptamine;|
| Placebo Comparator: Placebo<br>A placebo that looks the same and is in a similar bottle | Dietary Supplement: Placebo<br>* A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical<br>|

What is the study measuring?
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Primary Outcome Measures

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