A Study to Evaluate Unintended Prolonged Opioid Use

Study Overview
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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.

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.

Official Title
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Unintended Prolonged Opioid Use

Conditions
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Opioid Use

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |