SMART Brain Health in African-Americans (SMART)

A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Opioid Use Disorder; Substance Use Disorders; Dopamine Dysregulation Syndrome; African Americans
• Intervention / Treatment: Dietary supplement: KB220Z; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20059
      • Recruiting
      • Howard University
      • Contact: Beverlyn Settles-Reaves, Ph.D.; Phone Number: 202-806-7707; Email: bsettles-reaves@howard.edu
      • Contact: Marjorie C. Gondré-Lewis, PhD; Phone Number: 202-806-5274; Email: mgondre-lewis@Howard.edu
      • Sub-Investigator: Tanya Alim, MD
    • Washington, District of Columbia, United States, 20059
      • Enrolling by invitation
      • Medical Home Development Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nutraceutical, KB220Z; A nutraceutical pill containing pro-dopamine precursors	Dietary supplement: KB220Z; Acts to enhance dopamine; Other Names: KB220; Synaptamine
PLACEBO_COMPARATOR: Placebo; A placebo that looks the same and is in a similar bottle	Dietary supplement: Placebo; A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Howard University
• Collaborators: Medical Home Development Group; Geneus Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 16, 2018
• Primary Completion (ANTICIPATED): August 30, 2019
• Study Completion (ANTICIPATED): August 30, 2019

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (ACTUAL): March 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Disease; Opioid-Related Disorders
• Other Study ID Numbers: R41MD012318-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The genetic data will be shared when compiled
• IPD Sharing Time Frame: within 18 months following completion of the study, and the cleaning of clinical and genomic data
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No