African Americans, Dopamine Dysregulation Syndrome, Opioid Use Disorder, Substance Use Disorders
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKB220Z
Acts to enhance dopamine
DIETARY_SUPPLEMENTPlacebo
A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical
Sponsors
Medical Home Development Group
Geneus Health
Howard University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Relapse | 4 months | Number of times opioids and other types of drugs of abuse are detected in urine |
| 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 |
| 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 |
| Addiction Severity Index (ASI) | 4 months | Change in indices associated with addiction and associated behaviors |
| Vitamin B6 testing | Month 4 | Presence of B6 in blood to test for compliance with Nutraceutical |
Countries
United States
Contacts
Primary ContactMarjorie C. Gondré-Lewis, Ph.D.
Backup ContactBeverlyn Settles-Reaves, Ph.D.
Outcome results
None listed