Opioid Use DisorderNCT07135323
AvertD Post-Approval Study
An observational study of Opioid Use Disorder, run by Prescient Medicine Holdings, Inc. at 1 site in United States.
Trial summary
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Opioid Used Disorder Risk Assessment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects being considered for first oral opioid prescription (4-30 days)
Who may be able to join
- ≥18 years of age
- Prior to first opioid prescription
- Being considered for first oral opioid prescription (4-30 days)
- Prescribed AvertD as part of care
- Willing and able to complete yearly assessments for 5 years
- Signed informed consent
Who cannot join
- Planned opioid prescription <4 or >30 days
- Any condition making participation unsafe or infeasible per investigator judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Concentrics Research
Indianapolis, Indiana, 46240
About this study
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population
- Conditions
- Opioid Use Disorder
- Being tested
- Opioid Used Disorder Risk Assessment
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Used Disorder Risk AssessmentGenetic
Determine the likelihood of Opioid Used Disorder prior to prescribing opioids
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of AvertD
Comparison of Averted results to diagnosis of Opioid Used Disorder from M.I.N.I. tool
Measured: Measured over 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Nov 2024
- Primary completionNov 2031 (estimated)
- Study completionNov 2031 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prescient Medicine Holdings, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Caron Treatment Centers, Concentrics Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135323
- Sponsor's protocol ID
- TP-60418
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AvertD Post-Approval Study
- ClinicalTrials.gov ID
- NCT07135323
- Acronym / sponsor ID
- TP-60418
- Conditions
- Opioid Use Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Prescient Medicine Holdings, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Caron Treatment Centers, Concentrics Research
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 22 Aug 2025 (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.
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects being considered for first oral opioid prescription (4-30 days)
Key inclusion criteria (6 listed)
- ≥18 years of age
- Prior to first opioid prescription
- Being considered for first oral opioid prescription (4-30 days)
- Prescribed AvertD as part of care
- Willing and able to complete yearly assessments for 5 years
Key exclusion criteria (2 listed)
- Planned opioid prescription <4 or >30 days
- Any condition making participation unsafe or infeasible per investigator judgment
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 |
|---|---|---|
| Opioid Used Disorder Risk AssessmentDetermine the likelihood of Opioid Used Disorder prior to prescribing opioids | Genetic | – |
Primary outcome
Sensitivity and Specificity of AvertD
Time frame: Measured over 5 years
Comparison of Averted results to diagnosis of Opioid Used Disorder from M.I.N.I. tool
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by Prescient Medicine Holdings, Inc. at 1 site 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Smith, MD (800-800-5525, amanda.smith@concentricsresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of AvertD (time frame: Measured over 5 years). 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 22 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.