Medication Maintenance Therapy in Community Pharmacy Settings

NCT03766893 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 1112133
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine how the pharmacy can better optimize treatment expansion by providing pharmacy-based medication assisted treatment (MAT) for maintenance under a collaborative pharmacy practice agreement.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (4)

• Pharmacists' dispensing of MAT medications

  Measured by the number of MAT medications dispensed from a study pharmacy according to the pharmacy records, over the one month pilot period.

  up to one month

• Pharmacists' monitoring of MAT care

  Measured by the number of toxicological drug screens performed at a study pharmacy over the one month pilot period.

  up to one month

• Pharmacist-reported feasibility of executing the collaborative pharmacy practice: agreement for MAT: Likert scale

  7-point Likert scale item assessing the pharmacist's view of the overall model feasibility. The item asks: How acceptable is providing buprenorphine/Suboxone care at the pharmacy? With responses ranging from 1 to 7 as: 1. totally unacceptable 2. unacceptable 3. slightly unacceptable 4. neutral 5. slightly acceptable 6. acceptable 7. perfectly acceptable Higher scores represent better outcome (i.e., endorsement of acceptability of the model), according to the pharmacists.

  up to one month

• Patient acceptability of pharmacy-provided MAT care: Likert scale

  7-point Likert scale item assessing overall acceptability of the pharmacy MAT model. The item asks: How acceptable is going to the pharmacy for your buprenorphine/Suboxone care? With responses ranging from 1 to 7 as: 1. totally unacceptable 2. unacceptable 3. slightly unacceptable 4. neutral 5. slightly acceptable 6. acceptable 7. perfectly acceptable Higher scores represent better outcome (i.e., high endorsement of acceptability of the model), according to the patients.

  up to one month

Study Arms (1)

Pharmacy based opioid use disorder care

EXPERIMENTAL

A single-arm pilot study to test the collaborative pharmacy practice agreement for MAT (using the medications buprenorphine or injectable naltrexone) care model with up to 12 patients with opioid use disorder, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.

Drug: Buprenorphine / Naloxone Oral Product; Drug: injectable naltrexone; Other: Pharmacy maintenance addiction care

Interventions

Buprenorphine / Naloxone Oral Product DRUG

To treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly (buprenorphine/naloxone) basis, unless the care plan specifies greater frequency of pharmacy visit. The median expected dose of buprenorphine/naloxone (sublingual film or tablet) is 8 to 24 mg daily, and may be adjusted per the collaborative pharmacy practice agreement.

Pharmacy based opioid use disorder care

injectable naltrexone DRUG

To treat opioid use disorder, injectable naltrexone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a monthly (injectable naltrexone) basis. The expected dose of injectable naltrexone will be approximately 380 mg. Injectable naltrexone will be dispensed and prepared by the pharmacist but administered by nursing staff for the pilot study.

Pharmacy based opioid use disorder care

Pharmacy maintenance addiction care OTHER

Patients on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for one month. Patients will visit weekly for check-ins with a pharmacist. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it once by the pharmacist during the pilot. All patients will visit the pharmacy at least weekly for addiction care (assessment, toxicological testing).

Pharmacy based opioid use disorder care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• English speaking; currently enrolled at a CODAC site in Rhode Island for the treatment of opioid use disorder;
• maintained on a stable dose of buprenorphine or injectable naltrexone for at least 2 days;
• no stable co-morbid illnesses likely to progress clinically during the pilot study;
• able and willing to provide written informed consent and locator information (working telephone and \>2 contacts) to participate.

You may not qualify if:

• currently pregnant or trying to get pregnant;
• plans to move or leave the state during the study, including pending legal action;
• self reported past year suicide attempt or self-reported past year suicidal thoughts with a plan;
• any condition that, in the researchers' judgment, interferes with safe study participation or adherence to study procedures, including but not limited to a mental, medical or other substance use disorder that is likely to require ongoing, intense clinical management during the pilot study.

Sponsors & Collaborators

• Lifespan: lead
• University of Rhode Island: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Traci C Green

  Lifespan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist, Associate Professor of Emergency Medicine

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: December 6, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

US (1)