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| Name | Class |
|---|---|
| Medical Home Development Group | UNKNOWN |
| Geneus Health | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutraceutical, KB220Z | Experimental | A nutraceutical pill containing pro-dopamine precursors |
|
| Placebo | Placebo Comparator | A placebo that looks the same and is in a similar bottle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KB220Z | Dietary Supplement | Acts to enhance dopamine |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjorie C. Gondré-Lewis, Ph.D. | Contact | 202-806-5274 | mgondre-lewis@Howard.edu | |
| Beverlyn Settles-Reaves, Ph.D. | Contact | 202-806-7707 | bsettles-reaves@howard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard University | Recruiting | Washington D.C. | District of Columbia | 20059 | United States |
The genetic data will be shared when compiled
within 18 months following completion of the study, and the cleaning of clinical and genomic data
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000601005 | KB220Z |
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Participants are assigned to one of two or more groups in parallel for the duration of the study
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| Placebo | Dietary Supplement | A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical |
|
| Medical Home Development Group | Enrolling by invitation | Washington D.C. | District of Columbia | 20059 | United States |