search
Back to results

SMART Brain Health in African-Americans (SMART)

Primary Purpose

Opioid Use Disorder, Substance Use Disorders, Dopamine Dysregulation Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
KB220Z
Placebo
Sponsored by
Howard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Howard UniversityRecruiting
  • Medical Home Development Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutraceutical, KB220Z

Placebo

Arm Description

A nutraceutical pill containing pro-dopamine precursors

A placebo that looks the same and is in a similar bottle

Outcomes

Primary Outcome Measures

Drug Relapse
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
Number of reward gene variants in opioid use disorder patients compared to controls
Change in assessment of depression, anxiety, PTSD
Change from Baseline in from the Comprehensive Universal Behavioral Screen for depression, anxiety, PTSD, after 4 months
Change in Reward Deficiency Syndrome Questionnaire (RDSQ)
Change in risky behaviors
Addiction Severity Index (ASI)
Change in indices associated with addiction and associated behaviors
Vitamin B6 testing
Presence of B6 in blood to test for compliance with Nutraceutical

Secondary Outcome Measures

Full Information

First Posted
July 16, 2018
Last Updated
March 1, 2019
Sponsor
Howard University
Collaborators
Medical Home Development Group, Geneus Health
search

1. Study Identification

Unique Protocol Identification Number
NCT03861832
Brief Title
SMART Brain Health in African-Americans
Acronym
SMART
Official Title
A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Howard University
Collaborators
Medical Home Development Group, Geneus Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Substance Use Disorders, Dopamine Dysregulation Syndrome, African Americans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutraceutical, KB220Z
Arm Type
Experimental
Arm Description
A nutraceutical pill containing pro-dopamine precursors
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A placebo that looks the same and is in a similar bottle
Intervention Type
Dietary Supplement
Intervention Name(s)
KB220Z
Other Intervention Name(s)
KB220, Synaptamine
Intervention Description
Acts to enhance dopamine
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical
Primary Outcome Measure Information:
Title
Drug Relapse
Description
Number of times opioids and other types of drugs of abuse are detected in urine
Time Frame
4 months
Title
Genetic Testing for the number of risk alleles for Reward Genes through GARS
Description
Number of reward gene variants in opioid use disorder patients compared to controls
Time Frame
Month 1
Title
Change in assessment of depression, anxiety, PTSD
Description
Change from Baseline in from the Comprehensive Universal Behavioral Screen for depression, anxiety, PTSD, after 4 months
Time Frame
4 months
Title
Change in Reward Deficiency Syndrome Questionnaire (RDSQ)
Description
Change in risky behaviors
Time Frame
4 months
Title
Addiction Severity Index (ASI)
Description
Change in indices associated with addiction and associated behaviors
Time Frame
4 months
Title
Vitamin B6 testing
Description
Presence of B6 in blood to test for compliance with Nutraceutical
Time Frame
Month 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marjorie C. Gondré-Lewis, Ph.D.
Phone
202-806-5274
Email
mgondre-lewis@Howard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Beverlyn Settles-Reaves, Ph.D.
Phone
202-806-7707
Email
bsettles-reaves@howard.edu
Facility Information:
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjorie C. Gondré-Lewis, PhD
Phone
202-806-5274
Email
mgondre-lewis@Howard.edu
First Name & Middle Initial & Last Name & Degree
Beverlyn Settles-Reaves, Ph.D.
Phone
202-806-7707
Email
bsettles-reaves@howard.edu
First Name & Middle Initial & Last Name & Degree
Tanya Alim, MD
Facility Name
Medical Home Development Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

SMART Brain Health in African-Americans

We'll reach out to this number within 24 hrs