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Prescription Opioid Misuse: A Pharmacist-Led Intervention at Point of Service Efficacy Trial

Award Number: R01DA051546
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2021
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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Prescription Opioid Misuse: A Pharmacist-Led Intervention at Point of Service Efficacy Trial - ABSTRACT 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 pre- scribed 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 a an untapped resource to address prescription opioid misuse—especially when considering the >60,000 pharmacies employing >170,000 pharmacists in the US. We have established preliminary data that provides important support for the current project: (1) pharmacists are concerned about misuse but need training and resources to become in- volved; (2) community pharmacy patients can be screened successfully for misuse in these settings; (3) we have established an integrated care intervention amenable to current pharmacy practice—Brief Intervention-Medica- tion Therapy Management (BI-MTM); and (4) our pilot data has shown support for feasibility, acceptability, pre- liminary intervention efficacy. Encouraged by these findings, we now aim 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 random- ized 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. Our final Aim will explore latent transitions of baseline to post- intervention misuse classes by intervention group. This will be accomplished by using mixture modeling, specif- ically multi-group latent transition analysis. We will employ observed misuse indicators 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	000	5	11/14/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $600,020 )
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	001	5	4/10/2025	NON-COMPETING CONTINUATION	$60,002
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	000	5	1/23/2025	NON-COMPETING CONTINUATION	$540,018
														Subtotal = $600,020

Issue Date FY: 2024 ( Subtotal = $717,674 )
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	001	4	4/25/2024	NON-COMPETING CONTINUATION	$71,767
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	000	4	1/26/2024	NON-COMPETING CONTINUATION	$645,907
														Subtotal = $717,674

Issue Date FY: 2023 ( Subtotal = $722,123 )
2023	2023	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	000	3	1/12/2023	NON-COMPETING CONTINUATION	$722,123
														Subtotal = $722,123

Issue Date FY: 2022 ( Subtotal = $726,896 )
2022	2022	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	001	2	3/23/2022	NON-COMPETING CONTINUATION	$72,689
2022	2022	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	000	2	1/17/2022	NON-COMPETING CONTINUATION	$654,207
														Subtotal = $726,896

Issue Date FY: 2021 ( Subtotal = $747,266 )
2021	2021	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Drug Use and Addiction Research Programs	000	1	3/12/2021	NEW	$747,266
														Subtotal = $747,266

Grand Total All Awards = $3,513,979

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Prescription Opioid Misuse: A Pharmacist-Led Intervention at Point of Service Efficacy Trial

Award Number: R01DA051546

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/15/2021

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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