NCT07421102

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
10mo left

Started Apr 2026

Shorter than P25 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

February 12, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

mailing buprenorphinetransitions of careopioid use disorderbarriers to buprenorphine

Outcome Measures

Primary Outcomes (3)

  • Feasibility (successful receipt)

    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

    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

    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

Study Arms (1)

Mailed Medications

OTHER

There is no comparison arm. This pilot study evaluates the feasibility of mailing medications to patients.

Other: strategy of mailing buprenorphine

Interventions

This study examines the feasibility and preliminary effectiveness of mailing buprenorphine to overcome barriers such as transportation to obtaining buprenorphine from a pharmacy.

Mailed Medications

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Allison Smith, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a pilot study designed to study the strategy of mailing buprenorphine and examine feasibility and preliminary effects of the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor-Faculty

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations