A Study to Evaluate Unintended Prolonged Opioid Use

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1796 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-12-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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Opioid Use

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes