SMART Brain Health in African-Americans

Howard University

Status: Unknown

Conditions: Opioid Use Disorder; Substance Use Disorders; Dopamine Dysregulation Syndrome; African Americans

Treatments: Dietary Supplement: Placebo; Dietary Supplement: KB220Z

Study type: Interventional

Funder types: Other

Identifiers

NCT03861832

R41MD012318-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Nutraceutical, KB220Z

Experimental group

Description:

A nutraceutical pill containing pro-dopamine precursors

Treatment:

Dietary Supplement: KB220Z

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo