SMART Brain Health in African-Americans

Substance Use Disorders Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03861832
• Other study ID #: R41MD012318-01
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: March 2019
• Source: Howard University
• Contact: Marjorie C. Gondré-Lewis, Ph.D.
• Phone: 202-806-5274
• Email: mgondre-lewis[@]Howard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• African Americans
• Disease
• Dopamine Dysregulation Syndrome
• Opioid Use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Dietary Supplement:
• KB220Z
Acts to enhance dopamine
• Placebo
A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical

Locations

Country	Name	City	State
United States	Howard University	Washington	District of Columbia
United States	Medical Home Development Group	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Howard University	Geneus Health, Medical Home Development Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Relapse	Number of times opioids and other types of drugs of abuse are detected in urine	4 months
Primary	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
Primary	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
Primary	Change in Reward Deficiency Syndrome Questionnaire (RDSQ)	Change in risky behaviors	4 months
Primary	Addiction Severity Index (ASI)	Change in indices associated with addiction and associated behaviors	4 months
Primary	Vitamin B6 testing	Presence of B6 in blood to test for compliance with Nutraceutical	Month 4