Pilot of Mailing Buprenorphine

April 9, 2026 updated by: Allison Smith, Medical University of South Carolina

A Pragmatic Remote Approach to Improve Transitions of Care and Retention in Opioid Use Disorder Treatment

This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of mailing buprenorphine to individuals with opioid use disorder (OUD) following medical hospitalization. The intervention aims to improve retention in treatment by overcoming barriers such as transportation and pharmacy access.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-center, hybrid type 3 pilot study will enroll 20 medically hospitalized patients with OUD who are initiated on buprenorphine during their inpatient stay. Participants will be discharged with a supply of buprenorphine and enrolled in the MOUD Direct Delivery (MOUDDD) Program, which mails monthly refills directly to their homes. The study will evaluate the feasibility (successful delivery), acceptability (patient-reported measures), and preliminary effectiveness (treatment retention at 1, 3, and 6 months) of mailing buprenorphine. Secondary outcomes include quality of life, adherence, overdose, and healthcare utilization. The intervention leverages existing mail-order pharmacy protocols and aims to inform scalable strategies for improving transitions of care and retention in OUD treatment.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Allison Smith, MD
        • Contact:
        • Contact:
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Allison Smith, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18
  • English-speaking
  • Diagnosed with OUD and initiated on buprenorphine during hospitalization
  • Discharging to a South Carolina address with a stable mailbox
  • Access to phone or computer

Exclusion Criteria:

  • Active psychosis or suicidal ideation
  • Severe medical or neurocognitive impairment
  • Pending incarceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Mailed Medications
There is no comparison arm. This pilot study evaluates the feasibility of mailing medications to patients.
Other: strategy of mailing buprenorphine
This study examines the feasibility and preliminary effectiveness of mailing buprenorphine to overcome barriers such as transportation to obtaining buprenorphine from a pharmacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (successful receipt)
Time Frame: From enrollment to the end of the study at 6 months
Successful delivery and receipt of medication defined by self-report and phone/text/video confirmation to receive code
From enrollment to the end of the study at 6 months
Successful receipt
Time Frame: From enrollment to the end of study at 6 months.
Feasibility is defined by the successful receipt of the buprenorphine prescriptions in the mail by the intended participants. Successful receipt defined by self-report and phone/text/video confirmation from participant. Delivery failure is defined as delay in receipt of medication by >48 hours by the mail delivery service.
From enrollment to the end of study at 6 months.
Retention in treatment
Time Frame: time of study enrollment to end of study at 6 months
Preliminary effectiveness of mailing buprenorphine will be measured by retention in treatment. This is defined by the proportion of participants retained in buprenorphine treatment at 1,3, and 6 months after discharge.
time of study enrollment to end of study at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Allison Smith, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00146867
  • K12DA031794 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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