Unintended Prolonged Opioid Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 1,796
- Locations
- 1
- Primary Endpoint
- Assess the rate of long-term opioid use
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Assess patient factors associated with development of long-term opioid use(Six months)
Investigators
W. Michael Hooten
Principal Investigator
Mayo Clinic