Recruiting

Observational Study

Sponsor:

Howard University

Code:

NCT03861832

Conditions

Opioid Use Disorder

Substance Use Disorders

Dopamine Dysregulation Syndrome

African Americans

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

KB220Z

Placebo

Study Details

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.

Conditions

Opioid Use Disorder

Substance Use Disorders

Dopamine Dysregulation Syndrome

African Americans

Study ID

NCT03861832

Start date

Jun 16, 2018

Status verified date

Mar, 2019

Completion date

Aug 30, 2019

Anticipated

Primary completion date

Aug 30, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nutraceutical, KB220Z

A nutraceutical pill containing pro-dopamine precursors

placebo comparator: Placebo

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

Interventions

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

Primary outcome measure

  • Drug Relapse [ Time Frame: 4 months ]
  • Genetic Testing for the number of risk alleles for Reward Genes through GARS [ Time Frame: Month 1 ]
  • Change in assessment of depression, anxiety, PTSD [ Time Frame: 4 months ]
  • Change in Reward Deficiency Syndrome Questionnaire (RDSQ) [ Time Frame: 4 months ]
  • Addiction Severity Index (ASI) [ Time Frame: 4 months ]
  • Vitamin B6 testing [ Time Frame: Month 4 ]

Central Contacts and Locations

Central contacts

Marjorie C. Gondré-Lewis, Ph.D.

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

Beverlyn Settles-Reaves, Ph.D.

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

Locations

Howard University

Recruiting

Washington, District of Columbia, United States, 20059

Contacts

Marjorie C. Gondré-Lewis, PhD

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

Beverlyn Settles-Reaves, Ph.D.

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

More Information

Sponsor

Howard University

Last update posted

Mar 4, 2019

Last verified

Mar, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Howard University on 2019-03-04.