Opioid Dependence Treatment Therapies in Pregnancy
Status:
Completed
Trial end date:
2020-10-05
Target enrollment:
Participant gender:
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.