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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05790252
Other study ID # 202209093
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 26, 2023
Est. completion date December 31, 2025

Study information

Verified date July 2023
Source Washington University School of Medicine
Contact Cassandra J Trammel, MD, MBA
Phone 314-121-1129
Email cjtrammel@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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


Intervention

Drug:
Buprenorphine Transdermal Matrix Patch
Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.
Other:
Sham patch
Bandage applied at time of induction initiation and removed at 48 hours.

Locations

Country Name City State
United States Washington University in St. Louis Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Induction withdrawal severity Subjective Opioid Withdrawal Scale (SOWS) scores collected during buprenorphine induction. SOWS scores range from 0-64 with higher scores representing worse withdrawal. Mild withdrawal is defined as scores 0-10, moderate as 11-20, and severe as 21+. Days 0 through 4
Secondary Induction success Induction success, a binary defined by fulling all of the following:
attendance at 1 week follow up (yes/no)
buprenorphine in urine at initial follow up (positive/negative on urine drug screening)
and absence of precipitated withdrawal (yes/no)
Days 0 through 7
Secondary Treatment adherence defined as percent of urine drug screens positive for buprenorphine throughout pregnancy Days 0 through delivery
Secondary Recovery success defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care Days 0 through delivery
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