NCT03861832

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

March 4, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

July 16, 2018

Last Update Submit

March 1, 2019

Conditions

Opioid Use DisorderSubstance Use DisordersDopamine Dysregulation SyndromeAfrican Americans

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Nutraceutical, KB220Z

EXPERIMENTAL

A nutraceutical pill containing pro-dopamine precursors

Dietary Supplement: KB220Z

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

KB220ZDIETARY_SUPPLEMENT

Acts to enhance dopamine

Also known as: KB220, Synaptamine
Nutraceutical, KB220Z
PlaceboDIETARY_SUPPLEMENT

A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical

Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Clinical Diagnosis of Alzheimer's disease/Dementia
  • Clinical Diagnosis of Schizophrenia
  • Clinical Diagnosis of a terminal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Howard University

Washington D.C., District of Columbia, 20059, United States

RECRUITING

Medical Home Development Group

Washington D.C., District of Columbia, 20059, United States

ENROLLING BY INVITATION

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

KB220Z

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Marjorie C. Gondré-Lewis, Ph.D.

CONTACT

202-806-5274mgondre-lewis@Howard.edu

Beverlyn Settles-Reaves, Ph.D.

CONTACT

202-806-7707bsettles-reaves@howard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2018

First Posted

March 4, 2019

Study Start

June 16, 2018

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

March 4, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

The genetic data will be shared when compiled

Shared Documents
CSR
Time Frame
within 18 months following completion of the study, and the cleaning of clinical and genomic data

Locations

US(2)