20 Participants NeededMy employer runs this trial

Mailing Buprenorphine for Opioid Use Disorder

Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Medical University of South Carolina
Must be taking: Buprenorphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with opioid use disorder (OUD) by mailing them the medication buprenorphine after hospital discharge. The goal is to simplify treatment adherence by eliminating barriers like pharmacy visits. As a pilot study, it is in the early stages and examines whether this approach is feasible and accepted by patients. Suitable candidates should have OUD, have started buprenorphine in the hospital, and possess a stable mailbox in South Carolina. As an Early Phase 1 trial, this study evaluates the feasibility and acceptance of this innovative treatment approach in real-world settings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that mailing buprenorphine is likely to be safe for individuals with opioid use disorder?

Past studies have shown that buprenorphine is a safe treatment for opioid use disorder (OUD). Research indicates it can lower the risk of overdose and other negative outcomes for patients. For example, some studies found that buprenorphine helps reduce opioid use and increases the likelihood of adherence to treatment plans.

The treatment is well-tolerated, with fewer side effects compared to medications like methadone. Buprenorphine is safe enough to have received approval for treating OUD in various settings, including emergency rooms.

While sending buprenorphine through the mail is a new method under study, the medication itself has a strong safety record for treating OUD.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about mailing buprenorphine for opioid use disorder because it introduces a new method of delivering treatment directly to patients' homes. Unlike traditional methods where patients must visit a clinic or pharmacy to receive their medication, this approach could significantly improve accessibility and convenience, especially for those with mobility issues or living in remote areas. By making it easier for patients to adhere to their medication regimen, this method has the potential to enhance treatment outcomes and reduce the barriers to managing opioid use disorder.

What evidence suggests that mailing buprenorphine is effective for opioid use disorder?

Studies have shown that buprenorphine effectively treats opioid use disorder (OUD). One study revealed that patients taking buprenorphine had a significantly lower risk of death and a higher likelihood of recovery. Another study found that half of the patients who received buprenorphine in an emergency room continued their treatment a month later. Research also indicates that medications like buprenorphine greatly reduce the chances of overdose and death for people with OUD. This trial will assess the feasibility of mailing buprenorphine, potentially making it easier for people to access the medication and remain in treatment.16789

Who Is on the Research Team?

AS

Allison Smith, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults (18+) who speak English, have opioid use disorder, started buprenorphine in the hospital, and are being discharged to a stable address in South Carolina with mailbox access. People with severe medical or mental health issues or pending jail time can't join.

Inclusion Criteria

Access to phone or computer
I am 18 years old or older.
English-speaking
See 2 more

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive buprenorphine during their inpatient stay and are enrolled in the MOUD Direct Delivery Program for monthly mail delivery of medication

6 months
Monthly virtual check-ins

Follow-up

Participants are monitored for retention in treatment and other outcomes such as quality of life and healthcare utilization

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Mailing Buprenorphine

Trial Overview

The study tests whether mailing buprenorphine to people after they leave the hospital helps them stay in treatment for opioid use disorder. It looks at how practical and acceptable this approach is.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mailed MedicationsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Patient outcomes following buprenorphine treatment for opioid ...

The aim of this study was to assess the influence of patient‐ and prescriber‐level characteristics relative to several patient outcomes following the ...

Treatment for Opioid Use Disorder: Population Estimates

Medications for opioid use disorder (OUD), particularly buprenorphine and methadone, substantially reduce overdose-related and overall mortality ...

Emergency Department Access to Buprenorphine for ...

In this cohort study of 464 patients with OUD, 86% received buprenorphine treatment in the ED and 50% remained engaged in OUD treatment 1 month later.

Buprenorphine-Naloxone for Opioid Use Disorder - PMC - NIH

Buprenorphine-naloxone was associated with significantly reduced mortality and increased remission rates for patients with opioid use disorder.

Enhancing Outcomes in Opioid Use Disorder Treatment

With the implementation of blister-packaging buprenorphine, adherence rates increased from 37.1% of patients in the pre-intervention period to 45.3%, resulting ...

Effectiveness and safety of therapies for patients with ...

The study showed that BUP-XR may offer advantages in treatment retention and abstinence over other OUD therapies. Additionally, BUP-XR showed ...

Strategy of mailing buprenorphine in Opioid Use Disorder

This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of mailing buprenorphine to individuals with opioid ...

Association Between Buprenorphine for Opioid Use ...

The primary outcome was death up to 5 years from treatment initiation by suicide and overdose combined; secondary outcomes included suicide, overdose, opioid- ...

553 Outcomes of Emergency Department-Initiated ...

All had documented opioid withdrawal, and 41% had a recorded pre-treatment COWS score (mean 12), while 29% had post-treatment scores (mean 5.6), indicating ...