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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
140
Howard University
Washington D.C., District of Columbia, United States
RECRUITINGMedical Home Development Group
Washington D.C., District of Columbia, United States
ENROLLING_BY_INVITATIONDrug Relapse
Number of times opioids and other types of drugs of abuse are detected in urine
Time frame: 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
Time frame: 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
Time frame: 4 months
Change in Reward Deficiency Syndrome Questionnaire (RDSQ)
Change in risky behaviors
Time frame: 4 months
Addiction Severity Index (ASI)
Change in indices associated with addiction and associated behaviors
Time frame: 4 months
Vitamin B6 testing
Presence of B6 in blood to test for compliance with Nutraceutical
Time frame: Month 4
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