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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03936985
Other study ID # CTN-0093
Secondary ID 5UG1DA049444
Status Completed
Phase
First received
Last updated
Start date November 4, 2019
Est. completion date May 31, 2023

Study information

Verified date June 2023
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of the study is to validate a Prescription Drug Monitoring Program-based opioid risk metric to discriminate between low, moderate, and high-risk opioid use disorder. The World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST) will be used as the gold standard instrument that defines patient risk levels. No intervention or hypothesis will be tested.


Description:

Fatal overdose deaths involving prescription opioids, heroin, and synthetic opioids has continued to increase across the US-continuing to increase in 35 states from 2013-2017. Given these persistent trends for adverse opioid-related outcomes in populations across the US, it is critical to work to identify those who are at risk, deliver appropriate care that will help prevent progression to more severe opioid-related outcomes, and provide referral and treatment resources to those who suffer from opioid use disorder. Therefore, it is necessary to expand the continuum of care to health care settings that previously may have been underutilized. One underutilized resource for addressing the current opioid epidemic is community pharmacies.The most important clinical tool pharmacists have available to identify possible misuse of opioid medications is prescription drug monitoring programs (PDMP),which capture patient-level prescription dispensing information to inform monitoring, dispensing decisions, and possible intervention.These tools are available in all US states and have the potential to enable pharmacists to identify patients at-risk for opioid-related adverse events, such as addiction and overdose. In light of the continued escalation of the opioid epidemic nationally, combined with the promising opportunities afforded by the further inclusion of community pharmacy settings for engaging patients with opioid-related risk, it is important to evaluate whether current PDMP risk metrics correlate with clinically validated opioid risk tools and if clinically meaningful risk cutoffs exist for PDMP risk metrics. This study will evaluate the concurrent validity of a PDMP-based opioid risk metric as a clinical measure of high risk opioid use and establish clinically useful risk-level thresholds relative to the widely validated gold standard of the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST). This study is a one group, cross-sectional, health assessment study. Participants who enroll in the study will complete on-line surveys at a single time point. Approximately 1,523 patients will be recruited from approximately 15 community community pharmacies. Trained pharmacy staff will inform potentially eligible participants, or individuals receiving at least one prescription(s) for potentially eligible participants, of the survey opportunity. Patients recruited will complete validated measures to assess opioid use and risk behaviors, substance use, and physical and mental health. A series of a priori analyses will be conducted to evaluate the validity of the PDMP-based opioid risk metric relative to the widely validated gold standard WHO ASSIST and to identify cutoff thresholds. Correlational, regression, and Cohen's Kappa statistical analyses will also be conducted to evaluate the relationship between the risk metric and the WHO ASSIST.


Recruitment information / eligibility

Status Completed
Enrollment 1461
Est. completion date May 31, 2023
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. be dispensed =1 opioid medication (including tramadol) by a participating pharmacy; 2. be =18 years of age according to pharmacy data and self-report Exclusion Criteria: 1. solely filling buprenorphine or buprenorphine combination products i.e., patients receiving OUD treatment with no other opioid medication use; 2. currently receiving treatment for cancer; 3. having previously completed the survey; 4. having current involvement with the criminal justice system that has, or could, lead to incarceration

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Cincinnati Cincinnati Ohio
United States University of Utah Salt Lake City Utah

Sponsors (4)

Lead Sponsor Collaborator
University of Utah National Institute on Drug Abuse (NIDA), Purdue University, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug use severity Opioid use severity will be assessed using the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) 36 months
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