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OpenTrials
Completed

NCT Number: NCT04024397

A Study to Evaluate 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.

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Key information

Conditions

Opioid Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Assess patient factors associated with development of long-term opioid use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Unintended Prolonged Opioid Use

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2019
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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