Opioid UseNCT04024397
A Study to Evaluate Unintended Prolonged Opioid Use
An observational study of Opioid Use, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to better understand how people who are prescribed opioids for short-term use, go on to receive this type of medication on a longer-term basis. 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
- How many people
- 1,796 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 29 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any individual that receives an opioid prescription.
Who may be able to join
- Age ≥ 18 years
- No use of opioids for 6 months prior to the issuance of the initial opioid prescription
- Willingness to participate in all aspects of the study including use of the Hugo platform on their personal smartphone
Who cannot join
- Cancer-associated pain
- Concurrent treatment for cancer (e.g., chemotherapy, radiation therapy)
- Residence in an extended care facility
- Any operation or hospitalization within the past 6 months
- Mental health disorders that could impede functioning in an ambulatory care setting (e.g., schizophrenia, dementia)
- Non-English speaking individuals
- No smartphone
- Use of a pharmacy that is not compatible with the Hugo platform.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Unintended Prolonged Opioid Use
Researchers are trying to better understand how people who are prescribed opioids for short-term use, go on to receive this type of medication on a longer-term basis.
Read the detailed description
Identify incident cases of UPOU and prospectively assess their characteristics in comparison to new opioid users who do not progress to UPOU. At each site, opioid-naïve adults who receive opioid prescriptions will be enrolled. Opioid prescriptions (both written and filled) and self-reported opioid use will be followed, and those subjects progressing to UPOU will be identified in real time. Matched samples of patients who do and do not develop UPOU will be recruited for assessment of framework elements related to patient characteristics,including biochemical confirmation of opioid use, pain-related measures (including psychological variables), and medical and social histories. Using the information gathered in Aim 1, structural equation modeling will be utilized to evaluate the associations UPOU and the patient domain.
- Conditions
- Opioid Use
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the rate of long-term opioid use
At month 6 following the receipt of the initial opioid prescription, the status of opioid use will be assessed to determine the rate of converting to long-term use.
Measured: Six months
Secondary outcomes (1)
Assess patient factors associated with development of long-term opioid use
Patient factors potentially associated development of long-term opioid use will be assessed including depressive symptoms as measured using the Center for Epidemiological Studies-Depression Scale. Scores on the scale range from 0 to 60 where higher scores indicated greater levels of depression. A cut-off score of 27 or greater indicates clinically significant levels of depression.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Oct 2019
- Primary completion1 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, W. Michael Hooten, Mayo Clinic
- Investigators
- W. Michael Hooten, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024397
- Sponsor's protocol ID
- 18-010484
- Other IDs
- U01TR002743
- Status last verified
- Mar 2024
- First submitted
- 11 Jul 2019
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hooten WM, Erickson DJ, Chawarski M, Scholz NA, Waljee JF, Brummett CM, Jeffery MM. Unintended prolonged opioid use: a prospective case-control study. Pain. 2026 Jun 1;167(6):e180-e190. doi: 10.1097/j.pain.0000000000003945. Epub 2026 Mar 4.
PubMed 41800757Hooten WM, Erickson DJ, Chawarski M, Scholz NA, Waljee JF, Brummett CM, Jeffery MM. Unintended Prolonged Opioid Use: Protocol for a Case-Controlled Trial. JMIR Res Protoc. 2025 Mar 24;14:e72032. doi: 10.2196/72032.
PubMed 39992690
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unintended Prolonged Opioid Use
- ClinicalTrials.gov ID
- NCT04024397
- Acronym / sponsor ID
- 18-010484
- Conditions
- Opioid Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,796 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 18 Jul 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.
Researchers are trying to better understand how people who are prescribed opioids for short-term use, go on to receive this type of medication on a longer-term basis.
Detailed description
Identify incident cases of UPOU and prospectively assess their characteristics in comparison to new opioid users who do not progress to UPOU. At each site, opioid-naïve adults who receive opioid prescriptions will be enrolled. Opioid prescriptions (both written and filled) and self-reported opioid use will be followed, and those subjects progressing to UPOU will be identified in real time. Matched samples of patients who do and do not develop UPOU will be recruited for assessment of framework elements related to patient characteristics,including biochemical confirmation of opioid use, pain-related measures (including psychological variables), and medical and social histories. Using the information gathered in Aim 1, structural equation modeling will be utilized to evaluate the associations UPOU and the patient domain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any individual that receives an opioid prescription.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- No use of opioids for 6 months prior to the issuance of the initial opioid prescription
- Willingness to participate in all aspects of the study including use of the Hugo platform on their personal smartphone
Key exclusion criteria (8 listed)
- Cancer-associated pain
- Concurrent treatment for cancer (e.g., chemotherapy, radiation therapy)
- Residence in an extended care facility
- Any operation or hospitalization within the past 6 months
- Mental health disorders that could impede functioning in an ambulatory care setting (e.g., schizophrenia, dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the rate of long-term opioid use
Time frame: Six months
At month 6 following the receipt of the initial opioid prescription, the status of opioid use will be assessed to determine the rate of converting to long-term use.
1 secondary outcome
Assess patient factors associated with development of long-term opioid use
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 41800757Hooten WM, Erickson DJ, Chawarski M, Scholz NA, Waljee JF, Brummett CM, Jeffery MM. Unintended prolonged opioid use: a prospective case-control study. Pain. 2026 Jun 1;167(6):e180-e190. doi: 10.1097/j.pain.0000000000003945. Epub 2026 Mar 4.
- Derived from this study: PubMed 39992690Hooten WM, Erickson DJ, Chawarski M, Scholz NA, Waljee JF, Brummett CM, Jeffery MM. Unintended Prolonged Opioid Use: Protocol for a Case-Controlled Trial. JMIR Res Protoc. 2025 Mar 24;14:e72032. doi: 10.2196/72032.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
W. Michael Hooten, MD principal investigator
Mayo Clinic
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, run by Mayo Clinic 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 27 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the rate of long-term opioid use (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024397, which also lists 2 linked publications.
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 27 Mar 2024.