Opioid Dependence Treatment Therapies in Pregnancy

Summary

The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women.

A pilot study is critical to develop the outcome measures, assessment tools and participant tracking techniques necessary for a future, large-scale comparative effectiveness clinical trial. An examination of feasibility and acceptability will also allow use to characterize the subpopulations of OD pregnant women willing to participate in treatment randomization, identify patient and provider characteristics associated with established treatment preferences and inform the development of strategies to improve participation and enhance the generalizability of the future large-scale clinical trial.

Conditions

• Opioid-Related Disorders
• Pregnancy

Interventions

DRUG

Buprenorphine

This is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women.

DRUG

Methadone

This is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Elizabeth E Krans, MD, MSc · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-04-20

Primary Completion

2019-10-09

Completion

2020-10-05

Countries

• United States

Study Locations