Skip to main content
OpenTrials
Completed

NCT Number: NCT03149718

Community Pharmacists and Opioid Misuse

Opioid medication misuse and overdose have reached epidemic proportions in the US. Community pharmacy is a potentially valuable resource for addressing opioid medication misuse. This study will manualize and establish the feasibility, acceptability, and clinical effect of a community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence, eliminating misuse, connecting patients to additional care, and safeguarding against overdose.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Misuse Behavior Chemically-Induced Disorders Health Behavior Medication Adherence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Patient Acceptance of Health Care Patient Compliance Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Falk Pharmacy, Pittsburgh, Pennsylvania, United States

Loading trial locations.

About this study

The current small scale single-blinded randomized controlled study will build on our preliminary studies by manualizing and examining the feasibility, acceptability, and clinical effect for the Brief Intervention Medication Therapy Management (BI-MTM) model. BI-MTM is a multicomponent community pharmacy-based intervention. BI-MTM is designed to: (1) promote opioid medication regimen adherence, (2) reduce opioid medication misuse, (3) connect participants with patient navigation (a chronic condition care model) to increase self-management of health conditions that increase risk for misuse, and (4) provide naloxone rescue training referrals. Patients will be screened across 14 months for opioid medication misuse in an urban community pharmacy affiliated with a major medical system. Patients positive for misuse will be randomly assigned to BI-MTM (n=23) or Standard Medication Counseling (n=23). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling. This study will demonstrate feasibility and acceptability of BI-MTM for community pharmacy patients who misuse their opioid medications for future intervention implementation in a fully powered randomized trial. This study will also generate preliminary data regarding opioid medication misuse elimination and increases in participant self-management activation for comorbid health conditions that increase risk for misuse.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Opioid Misuse

-≥18 years

  • English speaking

Exclusion criteria

  • Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring)
  • Cannot provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
  • Do not have a reliable landline or mobile phone to be contacted by study staff
  • Are only filling buprenorphine (given some formulations are not indicated for pain)
  • Plan to leave the area for an extended period of time in the next 3 months
  • Have had a psychotic and/or manic episode in the last 30 days

Treatment and study plan

Brief Intervention Medication Therapy Management

Behavioral

BI-MTM is designed to: (1) eliminate opioid medication misuse, (2) promote opioid regimen adherence, (3) connect participants with Patient Navigation to increase patient self-management activation for health conditions that increase risk for misuse (Patient Navigation is an evidence-based chronic care intervention), and (4) provide naloxone rescue training referrals.

Standard Medication Counseling (SMC)

Behavioral

Standard Medication Counseling (SMC; n=23; i.e., treatment-as-usual condition). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling.

Primary outcomes

  1. Intervention feasibility

    Time frame: Month 21 of Study

    Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.

  2. Intervention acceptability

    Time frame: Month 21 of Study

    Intervention acceptability will be demonstrated though qualitative interviews.

Secondary outcomes

  1. Opioid Misuse

    Time frame: Month 21 of Study

    Opioid misuse will be demonstrated by the Prescription Opioid Misuse Index (POMI).

  2. Patient Self-Management

    Time frame: Month 21 of Study

    Patient self-management activation misuse than will be captured by the Patient Activation Measure.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Prescription Opioid Misuse: Pharmacist-Delivered Intervention at Point of Service

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 11, 2017
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.