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Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy

NCT03831113 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-08-29

Study results available
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Summary

This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental and neuroanatomic outcomes. Strategies to reduce opioid exposure will be explored. There are 4 specific aims but only specific aim 4 is a clinical trial and reported here. In specific aim 4, eligible consenting women on buprenorphine in an MAT clinic will be assigned to 2 dose reduction regimens and their response to dose reduction will be measured using a visual analog scale.

Conditions

  • Opiate Addiction
  • Pregnancy

Interventions

DRUG

Magnitude Group

Dose reductions will alternate between 1mg or 2 mg weekly until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.

DRUG

Frequency Group

Dose reductions of 2 mg will occur alternate between once weekly to biweekly until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Steve N. Caritis, MD

    lead OTHER

Principal Investigators

  • Steve Caritis, MD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-13
Primary Completion
2022-12-22
Completion
2022-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831113 on ClinicalTrials.gov