Opioid Use DisorderSMARTNCT03861832
SMART Brain Health in African-Americans
A study testing KB220Z in people with Opioid Use Disorder and Substance Use Disorders, run by Howard University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Substance Use Disorders, Dopamine Dysregulation Syndrome
- What is being tested?
- KB220Z
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jun 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical Diagnosis of Alzheimer's disease/Dementia
- Clinical Diagnosis of Schizophrenia
- Clinical Diagnosis of a terminal disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Howard University
Washington D.C., District of Columbia, 20059
Marjorie C. Gondré-Lewis, PhD, 202-806-5274, mgondre-lewis@Howard.edu
Beverlyn Settles-Reaves, Ph.D., 202-806-7707, bsettles-reaves@howard.edu
- Enrolling by invitation
Medical Home Development Group
Washington D.C., District of Columbia, 20059
About this study
Official title: A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder
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.
Read the 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.
- Conditions
- Opioid Use Disorder, Substance Use Disorders, Dopamine Dysregulation Syndrome, African Americans
- Being tested
- KB220Z, Placebo
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB220ZDietary supplement
Also called KB220, Synaptamine
Acts to enhance dopamine
PlaceboDietary supplement
A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical, KB220Z | Experimental | A nutraceutical pill containing pro-dopamine precursors Receives: Dietary Supplement: KB220Z |
| Placebo | Placebo comparator | A placebo that looks the same and is in a similar bottle Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Relapse
Number of times opioids and other types of drugs of abuse are detected in urine
Measured: 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
Measured: 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
Measured: 4 months
Change in Reward Deficiency Syndrome Questionnaire (RDSQ)
Change in risky behaviors
Measured: 4 months
Addiction Severity Index (ASI)
Change in indices associated with addiction and associated behaviors
Measured: 4 months
Vitamin B6 testing
Presence of B6 in blood to test for compliance with Nutraceutical
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start16 Jun 2018
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Home Development Group, Geneus Health
- Responsible party
- Principal investigator, Marjorie Gondre-Lewis, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861832
- Sponsor's protocol ID
- R41MD012318-01
- Acronym
- SMART
- Status last verified
- Mar 2019
- First submitted
- 16 Jul 2018
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The genetic data will be shared when compiled
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Medical Approach to Reward Transformation (SMART) for Brain Health in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT03861832
- Acronym / sponsor ID
- SMART / R41MD012318-01
- Conditions
- Opioid Use Disorder, Substance Use Disorders, Dopamine Dysregulation Syndrome, African Americans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Collaborators
- Medical Home Development Group, Geneus Health
- Study start
- 16 Jun 2018 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical, KB220Z | Experimental | Dietary Supplement: KB220ZA nutraceutical pill containing pro-dopamine precursors |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA placebo that looks the same and is in a similar bottle |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Clinical Diagnosis of Alzheimer's disease/Dementia
- Clinical Diagnosis of Schizophrenia
- Clinical Diagnosis of a terminal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB220ZAlso: KB220, SynaptamineActs to enhance dopamine | Dietary supplement | Nutraceutical, KB220Z |
| PlaceboA placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical | Dietary supplement | Placebo |
Primary outcome
Drug Relapse
Time frame: 4 months
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
Time frame: Month 1
Number of reward gene variants in opioid use disorder patients compared to controls
Change in assessment of depression, anxiety, PTSD
Time frame: 4 months
Change from Baseline in from the Comprehensive Universal Behavioral Screen for depression, anxiety, PTSD, after 4 months
Change in Reward Deficiency Syndrome Questionnaire (RDSQ)
Time frame: 4 months
Change in risky behaviors
Addiction Severity Index (ASI)
Time frame: 4 months
Change in indices associated with addiction and associated behaviors
Vitamin B6 testing
Time frame: Month 4
Presence of B6 in blood to test for compliance with Nutraceutical
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Individual participant dataSharing planned: Yes. The genetic data will be shared when compiled
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KB220Z in people with Opioid Use Disorder and Substance Use Disorders, run by Howard University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marjorie C. Gondré-Lewis, Ph.D. (202-806-5274, mgondre-lewis@Howard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Relapse (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.