Overview

Opioid Dependence Treatment Therapies in Pregnancy

Status:
Completed
Trial end date:
2020-10-05
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Analgesics, Opioid
Buprenorphine
Methadone
Criteria
Inclusion Criteria:

- Pregnant women 18+ years old, with a singleton pregnancy ≤ 28 weeks gestation
confirmed by ultrasound, who meet Diagnostic and Statistical Manual-IV criteria for
opioid dependence confirmed by urine drug screen (UDS), who are interested in opioid
maintenance treatment and plan to receive prenatal care and deliver at Magee Womens
Hospital (MWH) will be recruited.

Exclusion Criteria:

- (1) active, current dependence on benzodiazepines or alcohol

- (2) acute severe psychiatric condition in need of immediate treatment (e.g. suicidal
ideations)

- (3) pending or legal action that could prohibit or interfere with participation (e.g.
incarceration)

- (4) current, established treatment with methadone or buprenorphine. Exclusion criteria
are based on the Substance Abuse and Mental Health Services Administration (SAMHSA)
recommendations for office-based buprenorphine use.