Recruiting
Phase 3

BupRenorphine

Sponsor:

Washington University School of Medicine

Code:

NCT05790252

Conditions

Opioid Use Disorder

Pregnancy Related

Pregnancy, High Risk

Pregnancy Complications

Buprenorphine Withdrawal

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine Transdermal Matrix Patch

Sham patch

Study Details

Brief summary:

The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are:

1. Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder?
2. Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.

Conditions

Opioid Use Disorder

Pregnancy Related

Pregnancy, High Risk

Pregnancy Complications

Buprenorphine Withdrawal

Study ID

NCT05790252

Start date

Nov 27, 2023

Status verified date

Oct, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Viable pregnancy
  • Meet diagnostic criteria for opioid use disorder
  • Receive prenatal care through opioid use disorder specific clinic at our institution
  • Opioid use within 24 hours prior to presentation
  • Desire treatment with buprenorphine

Exclusion Criteria:

  • Patients already receiving treatment for opioid use disorder
  • History of prior induction attempt with buprenorphine
  • Active withdrawal at time of presentation
  • Medical contraindication to buprenorphine
  • Requiring immediate hospitalization

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bridge Induction Arm

placebo comparator: Standard Arm

Interventions

Buprenorphine Transdermal Matrix Patch

Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.

Sham patch

Bandage applied at time of induction initiation and removed at 48 hours.

Primary outcome measure

  • Induction withdrawal severity [ Time Frame: Days 0 through 4 ]

Central Contacts and Locations

Central contacts

Cassandra J Trammel, MD, MBA

314-121-1129cjtrammel@wustl.edu

Locations

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63124

Contacts

Jeannie Kelly, MD

jckelly@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-10-14.