Trials / Unknown
UnknownNCT03861832
SMART Brain Health in African-Americans
A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Howard University · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | KB220Z | Acts to enhance dopamine |
| DIETARY_SUPPLEMENT | Placebo | A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical |
Timeline
- Start date
- 2018-06-16
- Primary completion
- 2019-08-30
- Completion
- 2019-08-30
- First posted
- 2019-03-04
- Last updated
- 2019-03-04
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03861832. Inclusion in this directory is not an endorsement.