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Averting NAS Among Opioid-Using Young Women Receiving MAT Using Buprenorphine

NCT04611659 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-11-02

No results posted yet for this study

Summary

The primary objective of this study is to test the efficacy of a Motivational Interviewing and Educational Training intervention with immediate linkage to long acting reversible contraception (LARC) (hereafter known as MIET). MIET will be delivered to women of childbearing age (18-44) through the Meharry Addiction Clinic to women residing in Nashville, Tennessee.

There are two aims associated with this study. The primary aim is to determine the efficacy of MIET, to promote insertion of LARC among young, urban dwelling, low income women living with OUD and at-risk of unplanned pregnancy.

The primary endpoint of this aim are: 1) meeting with a provider regarding initial assessment for LARC, 2) having a LARC implant. Because of potential contraindication for LARC insertion (i.e. obesity) the first endpoint of meeting with a LARC provider is most proximal to aim 1. However, determining the number of willing women that go on to receive the implant is also critical in that it reflects potential decreases in cost to the health care system through reduction of unintended pregnancy and related subsequent NAS in the newborn.

The second aim for the study is to utilize qualitative and quantitative data collected for the study to modify the MIET intervention to more effectively meet the needs of the women in the study.

Survey data for the study will be collected at baseline, one and six months. Of note, the baseline, one and six month survey data collections will provide potential co-variates to consider in analysis of aim one and two. The primary endpoints however will come from the six month records review. We will gain consent to access records at the baseline consent, and will gather these data from the Meharry Electronic Health Record.

Conditions

  • Opioid-use Disorder
  • Contraception
  • Neonatal Abstinence Syndrome

Interventions

BEHAVIORAL

Motivational Interviewing and Educational Training (MIET)

Women in the intervention arm will receive a motivational interviewing intervention coupled with education on contraception and the potential for neonatal abstinence syndrome.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Meharry Medical College

    lead OTHER

Principal Investigators

  • Robert L Cooper, PhD · Meharry Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-07-31
Completion
2021-10-31

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 NCT04611659 on ClinicalTrials.gov