SMART Brain Health in African-Americans

Sponsor

Howard University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03861832

Collaborator

Medical Home Development Group (Other), Geneus Health (Other)

140

Enrollment

Locations

Arms

14.5

Anticipated Duration (Months)

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder Substance Use Disorders Dopamine Dysregulation Syndrome African Americans	Dietary Supplement: KB220Z Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are assigned to one of two or more groups in parallel for the duration of the studyParticipants are assigned to one of two or more groups in parallel for the duration of the study

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 16, 2018

Anticipated Primary Completion Date :

Aug 30, 2019

Anticipated Study Completion Date :

Aug 30, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Drug Relapse [4 months]
Number of times opioids and other types of drugs of abuse are detected in urine
Genetic Testing for the number of risk alleles for Reward Genes through GARS [Month 1]
Number of reward gene variants in opioid use disorder patients compared to controls
Change in assessment of depression, anxiety, PTSD [4 months]
Change from Baseline in from the Comprehensive Universal Behavioral Screen for depression, anxiety, PTSD, after 4 months
Change in Reward Deficiency Syndrome Questionnaire (RDSQ) [4 months]
Change in risky behaviors
Addiction Severity Index (ASI) [4 months]
Change in indices associated with addiction and associated behaviors
Vitamin B6 testing [Month 4]
Presence of B6 in blood to test for compliance with Nutraceutical

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Howard University	Washington	District of Columbia	United States	20059
2	Medical Home Development Group	Washington	District of Columbia	United States	20059

Sponsors and Collaborators

Howard University
Medical Home Development Group
Geneus Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marjorie Gondre-Lewis, Professor, Howard University

ClinicalTrials.gov Identifier:

NCT03861832

Other Study ID Numbers:

R41MD012318-01

First Posted:

Mar 4, 2019

Last Update Posted:

Mar 4, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Substance-Related Disorders

Opioid-Related Disorders

Study Results

No Results Posted as of Mar 4, 2019