Southern Consortium Node of the Clinical Trials Network

NIH RePORTER · NIH · UG1 · $1,651,467 · view on reporter.nih.gov ↗

Abstract

CTN0080: Medication treatment for Opioid use disorder in expectant Mothers (MOMS): a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations. The growing opioid-use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant opioid-dependent women and neonatal abstinence syndrome, which is associated with adverse health effects for the infant and with costly hospitalizations. Maintenance with sublingual (SL) buprenorphine (BUP) is efficacious for opioid use disorder but has disadvantages that may be heightened in pregnant women including the potential for poor adherence, treatment dropout, and negative maternal/fetal effects associated with daily BUP peak-trough cycles. Extended release (XR) formulations may address some of these disadvantages. The primary objective of CTN-0080 is to evaluate the impact of treating opioid use disorder in pregnant women with BUP-XR, compared to BUP-SL, on maternal-infant outcomes. Testing a conceptual model of the mechanisms by which BUP-XR may improve maternal-infant outcomes, relative to BUP-SL, is a secondary trial objective. CTN-0107: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) This project is a 3-site, randomized controlled trial using Peer Recovery Coaches trained in FORCE (FAVOR Overdose Recovery Coaching Evaluation), who will engage with opioid overdose survivors in the emergency department to get permission to follow up with them. The Coaches will follow a modified FORCE manual using a tied approach of engagement, utilizing motivational interviewing and strengths-based care management approach of engage participants in care and develop a patient-centered recovery plan. The FORCE intervention will be tailored to the participant's needs and will continue for 6 months after enrollment. This intervention will be compared to Treatment as Usual (TAU) in which overdose survivors receive referral to treatment. Outcomes include engagement in formal OUD treatment between groups, retention in treatment, and number of overdoses after enrollment. This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to improve treatment for opioid misuse and addiction.

Key facts

NIH application ID
10379694
Project number
3UG1DA013727-22S1
Recipient
MEDICAL UNIVERSITY OF SOUTH CAROLINA
Principal Investigator
KATHLEEN T. BRADY
Activity code
UG1
Funding institute
NIH
Fiscal year
2021
Award amount
$1,651,467
Award type
3
Project period
2000-09-30 → 2025-02-28