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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridge Induction Arm | Experimental |
| |
| Standard Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine Transdermal Matrix Patch | Drug | Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Induction success | Induction success, a binary defined by fulling all of the following:
| Days 0 through 7 |
| Treatment adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cassandra J Trammel, MD, MBA | Contact | 314-121-1129 | cjtrammel@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeannie C Kelly, MD, MS | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | Recruiting | St Louis | Missouri | 63124 | United States |
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| Sham patch | Other | Bandage applied at time of induction initiation and removed at 48 hours. |
|
defined as percent of urine drug screens positive for buprenorphine throughout pregnancy |
| Days 0 through delivery |
| Recovery success | defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care | Days 0 through delivery |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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