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A Study to Evaluate Unintended Prolonged Opioid Use

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Mayo Clinic

Status

Completed

Conditions

Opioid Use

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04024397
U01TR002743 (U.S. NIH Grant/Contract)
18-010484

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,796 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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