A Study to Evaluate Unintended Prolonged Opioid Use

Completed

• Conditions: Opioid Use

• Registration Number: NCT04024397
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Study Start: 2019-10-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1796

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the rate of long-term opioid use	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.

Secondary Outcome Measures

Name	Time	Method
Assess patient factors associated with development of long-term opioid use	Six months	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States