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Recruiting NCT07421102

Pilot of Mailing Buprenorphine

Early Phase I Interventional Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: strategy of mailing buprenorphine.
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility (successful receipt) [Time frame: 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.]
  • Retention in treatment [Time frame: time of study enrollment to end of study at 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • Medical University of South Carolina — Charleston
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT07421102 · Pro00146867 · K12DA031794

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗