Medication Maintenance Therapy in Community Pharmacy Settings

NCT04139213 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 9919
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare pharmacy-based medication assisted treatment (MAT) with usual care MAT for people with opioid use disorder.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (2)

• Retention in MAT

  Proportion of patients attending one or more visits with MAT providers every 30 days for up to 90 days post randomization according to the medical or pharmacy record

  up to 90 days post randomization

• Relapse to drug use

  Proportion of patients who relapse to drug use, defined as absence of the MAT medication and presence of heroin or other illicit opioids. Measured by toxicological (urine or oral) analysis, with samples collected at every visit (i.e., \<every 30 days), or at the 3-month interview at the research site. For patients attending visits, the toxicological results will consider those in the medical or pharmacy record. Urine or oral samples will test for drugs of abuse plus fentanyl, using a rapid qualitative immunoassay.

  up to 90 days post randomization

Secondary Outcomes (3)

• Primary care visits

  up to 90 days post randomization

• Emergency department visits

  up to 90 days post randomization

• Hospitalizations

  up to 90 days post randomization

Other Outcomes (1)

• Engagement in MAT

  up to 30 days post randomization

Study Arms (2)

Usual care

ACTIVE COMPARATOR

usual medication assisted treatment for maintenance care of opioid use disorder

Drug: buprenorphine/naloxone oral product; Drug: injectable naltrexone; Drug: oral naltrexone

Pharmacy MAT

EXPERIMENTAL

pharmacy-based medication assisted treatment for maintenance care of opioid use disorder

Drug: buprenorphine/naloxone oral product; Drug: injectable naltrexone; Other: Pharmacy maintenance addiction care; Drug: oral naltrexone

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 or monthly 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.

Also known as: Suboxone

Pharmacy MAT; Usual 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.

Also known as: Vivitrol

Pharmacy MAT; Usual care

Pharmacy maintenance addiction care OTHER

Patients randomized to the pharmacy study arm and on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for up to three months. Patients will visit for check-ins with a pharmacist on a monthly, weekly, or more frequent basis, depending on the individual treatment plan. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it monthly by the pharmacist. All patients will visit the pharmacy at least monthly for addiction care (assessment, toxicological testing).

Pharmacy MAT

oral naltrexone DRUG

To augment care for patients receiving injectable naltrexone for the treatment of OUD and treat cravings that may arise before their scheduled injection, patients prescribed injectable naltrexone may be provided a several day supply of oral naltrexone by a study pharmacist under a collaborative pharmacy practice agreement. The expected dose of oral naltrexone will be approximately 25-50 mg daily.

Pharmacy MAT; Usual 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 MAT site for the treatment of OUD, maintained on a stable MAT (BNX, NTX) dose for at least 2 days or interested in induction
• Able and willing to provide written informed consent and secondary contact

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;
• Patient is currently being treated for an acute illness or has a condition that is not stable including but not limited to an upcoming surgical procedure, hospitalization, or complex treatment regimen (e.g., chemotherapy, HCV treatment, has surgery scheduled, has procedures anticipated, has anticipated dose changes with other medication), that is likely to require ongoing, intense clinical management

Sponsors & Collaborators

• Lifespan: lead
• University of Rhode Island: collaborator
• The Miriam Hospital: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Green TC, Serafinski R, Clark SA, Rich JD, Bratberg J. Physician-Delegated Unobserved Induction with Buprenorphine in Pharmacies. N Engl J Med. 2023 Jan 12;388(2):185-186. doi: 10.1056/NEJMc2208055. No abstract available.

  PMID: 36630629 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination; vivitrol; Naltrexone

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; Naloxone; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Traci C Green, PhD, MSc

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: July 25, 2019
• Primary Completion: September 30, 2022
• Study Completion: October 1, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after 50% of the sample recruitment has been reached (n=125)
• Access Criteria: Other researchers may request data in writing from the principal investigator

Locations

US (1)