Clinical trial NCT05141266: Healthy Opioid Prescription Engagement
Official title: Healthy Opioid Prescription Engagement 2.0
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Misuse
Opioid-Related Disorders
Pharmacist-Patient Relations
Keywords: Community Pharmacies
Patient Navigation
Opioid intervention
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-02
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in opioid medication misuse.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Gerald Cochran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cochran G, Shen J, Cox N, Field C, Carlston K, Sengpraseut B, White A, Okifuji A, Jackman C, Haaland B, Ragsdale R, Gordon AJ, Tarter R. Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial. Contemp Clin Trials. 2022 May;116:106759. doi: 10.1016/j.cct.2022.106759. Epub 2022 Apr 11.