NCT04024397

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,796

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

4.2 years

First QC Date

July 11, 2019

Last Update Submit

March 25, 2024

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

  • 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.

    Six months

Secondary Outcomes (1)

  • Assess patient factors associated with development of long-term opioid use

    Six months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any individual that receives an opioid prescription.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Hooten 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.

    PMID: 39992690DERIVED

Related Links

Study Officials

  • W. Michael Hooten, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 18, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2023

Study Completion

December 29, 2023

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)