A Study to Evaluate Unintended Prolonged Opioid Use

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use

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 Type: Observational
• Enrollment (Actual): 1796

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Any individual that receives an opioid prescription.

Description

Inclusion Criteria:

• 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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: W. Michael Hooten, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18-010484; U01TR002743 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No