Opioid Use DisorderEarly Phase 1NCT07421102
Pilot of Mailing Buprenorphine
A Early Phase 1 study testing strategy of mailing buprenorphine in people with Opioid Use Disorder, run by Medical University of South Carolina at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- strategy of mailing buprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2026to Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active psychosis or suicidal ideation
- Severe medical or neurocognitive impairment
- Pending incarceration
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Allison Smith, MD, 843-792-2100, smithall@musc.edu
Allison Smith, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Primary Investigator, MD, 843-792-0686, smithall@musc.edu
Research Coordinator, BS, schneidh@musc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- strategy of mailing buprenorphine
- Keywords
- mailing buprenorphine, transitions of care, opioid use disorder, barriers to buprenorphine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strategy of mailing buprenorphineOther
This study examines the feasibility and preliminary effectiveness of mailing buprenorphine to overcome barriers such as transportation to obtaining buprenorphine from a pharmacy.
| Study group | Role | What they receive |
|---|---|---|
| Mailed Medications | Other | There is no comparison arm. This pilot study evaluates the feasibility of mailing medications to patients. Receives: Other: strategy of mailing buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (successful receipt)
Successful delivery and receipt of medication defined by self-report and phone/text/video confirmation to receive code
Measured: 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.
Measured: 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.
Measured: time of study enrollment to end of study at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start8 Apr 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study designed to study the strategy of mailing buprenorphine and examine feasibility and preliminary effects of the intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Allison Smith, Medical University of South Carolina
- Investigators
- Allison Smith, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421102
- Sponsor's protocol ID
- Pro00146867
- Other IDs
- K12DA031794
- Status last verified
- Apr 2026
- First submitted
- 12 Feb 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Remote Approach to Improve Transitions of Care and Retention in Opioid Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT07421102
- Acronym / sponsor ID
- Pro00146867
- Conditions
- Opioid Use Disorder
- Keywords
- mailing buprenorphine, transitions of care, opioid use disorder, barriers to buprenorphine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study designed to study the strategy of mailing buprenorphine and examine feasibility and preliminary effects of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Mailed Medications | Other | Other: strategy of mailing buprenorphineThere is no comparison arm. This pilot study evaluates the feasibility of mailing medications to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Active psychosis or suicidal ideation
- Severe medical or neurocognitive impairment
- Pending incarceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| strategy of mailing buprenorphineThis study examines the feasibility and preliminary effectiveness of mailing buprenorphine to overcome barriers such as transportation to obtaining buprenorphine from a pharmacy. | Other | Mailed Medications |
Primary outcome
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Smith, MD principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing strategy of mailing buprenorphine in people with Opioid Use Disorder, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (successful receipt) (time frame: From enrollment to the end of the study at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.