Community Pharmacists and Opioid Misuse

NCT ID: NCT03149718

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-06-01

Brief Summary

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.

Detailed Description

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.

Conditions

Opioid Misuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SMC (n=23)

Standard Medication Counseling.

Group Type: ACTIVE_COMPARATOR

Standard Medication Counseling (SMC)

Intervention Type: 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.

BI-MTM (n=23)

Brief Intervention Medication Therapy Management.

Group Type: EXPERIMENTAL

Brief Intervention Medication Therapy Management

Intervention Type: 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.

Interventions

Brief Intervention Medication Therapy Management

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.

Intervention Type: BEHAVIORAL

Standard Medication Counseling (SMC)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Jerry Cochran

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald Cochran, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Falk Pharmacy

Pittsburgh, Pennsylvania, United States

Medicine Shoppe

Somerset, Pennsylvania, United States

Countries

United States

Other Identifiers

R21DA043735

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO17010410

Identifier Type: -

Identifier Source: org_study_id