Clinical trial NCT03861832: SMART Brain Health in African-Americans
Official title: A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use Disorder
Substance Use Disorders
Dopamine Dysregulation Syndrome
African Americans
Lead sponsor: Howard University
Sponsor class: OTHER
Collaborators: name: Medical Home Development Group
name: Geneus Health
First posted: 2019-03-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Drug Relapse
timeFrame: 4 months
measure: Genetic Testing for the number of risk alleles for Reward Genes through GARS
timeFrame: Month 1
measure: Change in assessment of depression, anxiety, PTSD
timeFrame: 4 months
measure: Change in Reward Deficiency Syndrome Questionnaire (RDSQ)
timeFrame: 4 months
measure: Addiction Severity Index (ASI)
timeFrame: 4 months
measure: Vitamin B6 testing
timeFrame: Month 4
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Washington
country: United States
facility: Medical Home Development Group
state: District of Columbia
Study officials:
References: