SMART Brain Health in African-Americans

NCT ID: NCT03861832

Last Updated: 2019-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-16

Study Completion Date

2019-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Disorder Substance Use Disorders Dopamine Dysregulation Syndrome African Americans

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nutraceutical, KB220Z

A nutraceutical pill containing pro-dopamine precursors

Group Type EXPERIMENTAL

KB220Z

Intervention Type DIETARY_SUPPLEMENT

Acts to enhance dopamine

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

KB220Z

Acts to enhance dopamine

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

KB220 Synaptamine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Home Development Group

UNKNOWN

Sponsor Role collaborator

Geneus Health

UNKNOWN

Sponsor Role collaborator

Howard University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marjorie Gondre-Lewis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Howard University

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

Site Status RECRUITING

Medical Home Development Group

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

Site Status ENROLLING_BY_INVITATION

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marjorie C. Gondré-Lewis, Ph.D.

Role: CONTACT

202-806-5274

Beverlyn Settles-Reaves, Ph.D.

Role: CONTACT

202-806-7707

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marjorie C. Gondré-Lewis, PhD

Role: primary

202-806-5274

Beverlyn Settles-Reaves, Ph.D.

Role: backup

202-806-7707

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R41MD012318-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SMART Effectiveness Trial
NCT04464421 COMPLETED NA
Minds and Mentors Program- R33
NCT05363371 RECRUITING NA
Dynamic Treatment Regimes for Opioid Use Disorder
NCT07011758 NOT_YET_RECRUITING PHASE2