Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT05141266
Brief Summary:
This study is a randomized controlled trial across 14 community pharmacies to test the efficacy of the Brief Intervention-Medication Therapy Management intervention (BI-MTM). The establishment of the BI-MTM model will result in a major impact for addressing the opioid epidemic, preventing opioid use disorder and overdose, and safeguarding patient health in a novel community-based service setting.
Detailed Description:
This study examines a community pharmacy-based intervention to reduce opioid medication misuse. Despite a recent national decline in opioid prescribing, 10.3 million Americans in 2018 reported misusing a prescribed opioid, and within this population, \>36% of those who misused obtained the opioid medication by filling a prescription. The point of medication dispensing, namely, the community pharmacy, is an untapped resource to address prescription opioid misuse-especially when considering the \>60,000 pharmacies employing \>170,000 pharmacists in the US. This study aims to conduct a fully-powered RCT of the BI-MTM intervention in community pharmacy settings that will accomplish 3 Specific Aims. The first Aim will demonstrate the pharmacist-led BI-MTM intervention is superior to standard medication counseling (SMC) for mitigating opioid medication misuse. This will be accomplished by conducting a powered single-blinded randomized trial to test the efficacy of BI-MTM (n=175) vs. SMC (n=175). Participants will be screened/recruited for eligibility at point of dispensing in 14 community pharmacies in Utah, a high opioid prescribing and opioid-adverse event state. Participants will be assessed at baseline, 2, and 6 months for opioid medication misuse. Participant-level state prescription drug monitoring data will also be linked with patient outcomes to assess objective changes in medication misuse behaviors (e.g., early refills and doctor/pharmacy shopping). The second Aim will identify the pathway by which BI-MTM results in improvements for depression, pain, and subsequently opioid misuse. To accomplish this, a path analysis will assess relationships of BI-MTM: (1) on depression, pain, and misuse, (2) depression on misuse, and (3) pain on misuse. The final Aim will explore latent transitions of baseline to post-intervention misuse classes by intervention group. This will be accomplished by using mixture modeling, specifically multi-group latent transition analysis. The observed misuse indicators will be used to estimate latent class transitions across time, grouping by treatment condition and adjusting for baseline covariates. Completing SA1- 3 advance the understanding of BI-MTM efficacy and set the stage for a national multisite trial.
Study:
NCT05141266
Study Brief:
Protocol Section:
NCT05141266