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Bringing Education Through Technology, Empathic Listening, and Research (BETTER)

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Pregnancy Related

Treatments

Behavioral: technology-based program

Study type

Interventional

Funder types

Other

Identifiers

NCT05214118
HM20023314

Details and patient eligibility

About

The purpose of this study is to test a new educational technology-based program and brochure as a supplement to prenatal education from providers. The program provides education about common challenges that pregnant and parenting women receiving medication for Opioid Use Disorder (OUD) often face. Specifically, it addresses the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.

Enrollment

29 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Female
  2. ≥18 years of age
  3. Meet criteria for Opioid Use Disorder
  4. Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone)
  5. Pregnant (<34 weeks EGA)
  6. Initial in-person visit at OB MOTIVATE clinic for the current pregnancy ≤10 weeks ago

Exclusion criteria

  1. Considering/planning adoption
  2. Present with a serious cognitive/psychiatric impairment
  3. Existing language barriers making true informed consent impossible

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

29 participants in 2 patient groups

Brochure
No Intervention group
Technology-based program
Experimental group
Treatment:
Behavioral: technology-based program

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Dace S Svikis Pickens, PhD; Caitlin E Martin, MD, MPH

Data sourced from clinicaltrials.gov

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