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Clinical Determinants of Unintended Prolonged Opioid Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04024397
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 22, 2019
Information provided by (Responsible Party):
W. Michael Hooten, 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.

Condition or disease
Opioid Use

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.

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Study Type : Observational
Estimated Enrollment : 780 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Determinants of Unintended Prolonged Opioid Use: A Multicenter Observational Study
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any individual that receives an opioid prescription.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04024397

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Contact: Beth L Montonye, RN 507-538-4344
Contact: Brenda Anderson, RN 507-255-7157

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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: W. Michael Hooten, MD Mayo Clinic

Additional Information:
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Responsible Party: W. Michael Hooten, Principal Investigator, Mayo Clinic Identifier: NCT04024397     History of Changes
Other Study ID Numbers: 18-010484
U01TR002743 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No