A Study to Evaluate Unintended Prolonged Opioid Use

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-010484
    Sponsor Protocol Number: 18-010484

About this study

The primary purpose of this study is to identify patient characteristics that are associated with unintended prolonged opioid use (UPUO).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years old;
  • No use of opioids for 6 months prior to the issuance of the initial opioid prescription; and 
  • Willingness to participate in all aspects of the study including use of the Hugo platform on their personal smartphone.
  • Patients meeting these inclusion criteria will be further categorized based on CONSORT criteria.  Criteria for the long-term CONSORT category includes episodes of opioid prescribing lasting longer than 90 days and including 120 or more total days’ supply or 10 or more prescriptions.  Criteria for the episodic CONSORT category includes episodes lasting 90 days or longer with total days’ supply less than 120 and the total number of prescriptions filled was less than 10. Criteria for the short-term CONSORT category includes episodes of opioid prescribing lasting 90 days or less.  

Exclusion Criteria:

  • 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; and 
  • Use of a pharmacy that is not compatible with the Hugo platform.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

W. Michael Hooten, M.D.

Contact us for the latest status

Contact information:

Brenda Anderson R.N.

(507)255-7157

anderson.brenda@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20460649

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