NCT03149718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

May 5, 2017

Last Update Submit

October 11, 2019

Conditions

Opioid Misuse

Keywords

PharmacyInterventionMedication Adherence

Outcome Measures

Primary Outcomes (2)

  • Intervention feasibility

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

    Month 21 of Study

  • Intervention acceptability

    Intervention acceptability will be demonstrated though qualitative interviews.

    Month 21 of Study

Secondary Outcomes (2)

  • Opioid Misuse

    Month 21 of Study

  • Patient Self-Management

    Month 21 of Study

Study Arms (2)

SMC (n=23)

ACTIVE COMPARATOR

Standard Medication Counseling.

Behavioral: Standard Medication Counseling (SMC)

BI-MTM (n=23)

EXPERIMENTAL

Brief Intervention Medication Therapy Management.

Behavioral: Brief Intervention Medication Therapy Management

Interventions

Brief Intervention Medication Therapy ManagementBEHAVIORAL

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.

BI-MTM (n=23)
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.

SMC (n=23)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Opioid Misuse
  • ≥18 years
  • English speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Falk Pharmacy

Pittsburgh, Pennsylvania, 15213, United States

Location

Medicine Shoppe

Somerset, Pennsylvania, 15501, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersMedication Adherence

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Gerald Cochran, Ph.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 11, 2017

Study Start

September 15, 2017

Primary Completion

March 27, 2019

Study Completion

June 1, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Locations

US(2)