SMART Brain Health in African-Americans
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
- Opioid Use Disorder
- Substance Use Disorders
- Dopamine Dysregulation Syndrome
- African Americans
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Nutraceutical, KB220Z |
A nutraceutical pill containing pro-dopamine precursors |
|
Placebo Comparator Placebo |
A placebo that looks the same and is in a similar bottle |
|
Recruiting Locations
Washington, District of Columbia 20059
More Details
- Status
- Unknown status
- Sponsor
- Howard University
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.