A Study to Evaluate Unintended Prolonged Opioid Use

Opioid Use Clinical Trial

Official title:

Unintended Prolonged Opioid Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024397
• Other study ID #: 18-010484
• Secondary ID: U01TR002743
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: December 29, 2023

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1796
• Est. completion date: December 29, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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