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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05141266
Other study ID # 141016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 8, 2021
Est. completion date December 1, 2026

Study information

Verified date December 2023
Source University of Utah
Contact Gerald Cochran, PhD
Phone 801/213-0799
Email jerry.cochran@hsc.utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date December 1, 2026
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult (=18 years) - English speaking - Not receiving cancer treatment - Who have a positive opioid misuse screen on the POMI will be eligible to learn about this study Exclusion Criteria: - Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring - Can-not provide collateral contact information for =2 contact persons (to ensure consistent contact/follow up) - Do not have a reliable land line or mobile phone to be contacted by study staff - Are filling only buprenorphine (given some formulations are not indicated for pain) - Plan to leave the area for an extended period of time in the next 6 months - Have had a psychotic and/or manic episode in the last 30 days (before consent, patients will be asked to screen for psychosis - Do not provide permission to access their state prescription drug monitoring data.

Study Design


Intervention

Behavioral:
Patient Navigation
PN involves 8 weekly telephonic sessions lasting 30-45 minutes (telephonic to support lower-costs/sustainability). In session 1, the navigator reviews with the participant a report of scores from the baseline assessment to understand the participant's current health needs/challenges; session 1 also involves development of therapeutic alliance/rapport and goal setting. Sessions 2-4 focus on goal setting and identifying barriers and problem resolutions. The navigator elicits motivation and discusses this in context of readiness to change heath behavior and self-management skills. Sessions 2-4 also involve navigators supporting/assisting patients to fill out paperwork and enroll in needed social services and/or mental/behavioral/physical healthcare, including but not limited to primary care. Sessions 5-7 focus on encouraging and reinforcing treatment adherence, review-ing and identifying other care needs, and offering linkages to service providers as applicable
Other:
Standard Medication Counseling (SMC)
SMC participants receive a single medication information/counseling session delivered by a University of Utah pharmacist to: (1) offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present (not applicable to this study given all patients must screen in person), and (4) discuss generic substitution.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Jerry Cochran National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in opioid medication misuse. This outcome will be assessed using the Prescription Opioid Misuse Index (POMI). 6 months
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