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NCT Number: NCT06733649

Treatment Education for Perinatal Women and Their Community Support

The study evaluates the feasibility and acceptability of a 50 minute treatment education session for perinatal women with opioid use disorder and a community support person. The education session provides correct information about opioid agonist medications and neonatal abstinence syndrome.

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Key information

Conditions

Opioid Dependency Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Perinatal women with opioid disorder often face criticism by social network members for receiving opioid agonist treatment. Feeling stigmatized by others may impact willingness to start and remain in agonist treatment.

The present study evaluates the feasibility and acceptability of a 50 minute treatment education session for perinatal women who are treated using an agonist medication (methadone or buprenorphine) and community support chosen by the patient.

Study participants will be recruited from perinatal women who receive substance abuse treatment at the Center for Addiction and Pregnancy or Addiction Treatment Services at Johns Hopkins Bayview campus. These women will work with a counselor to select a community support person to bring to the program for the education session.

The session will provide correct information on opioid agonist medications and neonatal abstinence syndrome. This session will follow a structured outline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • perinatal women treated with agonist medication
  • interest in study participation
  • interest in community support:
  • interest in study participation

Exclusion criteria

  • perinatal women not treated with agonist medication
  • not interested in study participation
  • not interested in community support:
  • not interested in study participation

Treatment and study plan

substance abuse treatment education

Other

Perinatal women and the women's community support will receive a 50 minute education session that provides correct information on opioid agonist medications and neonatal abstinence syndrome.

Primary outcomes

  1. Percentage of women interested in study participation

    Time frame: Immediately before session 1

    Feasibility -- percentage of women interested in study participation

  2. Percentage of interested women who bring in community support to the education group

    Time frame: Immediately before session 1

    Acceptability -- proportion of interested women who bring in community support to the education group

Secondary outcomes

  1. Knowledge as assessed by survey

    Time frame: Baseline, Immediately after session 1

    Women and the womens' community support will complete a 10 question true / false test before and after the education session

Study contacts

Contact information is provided by the study sponsor or research team.

Denis Antoine, MD

CONTACT

[email protected]

410 550 7843

Michael Kidorf, Ph.D.

CONTACT

[email protected]

410 550 0006

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Treatment Education for Pre- and Postpartum Women and Their Community Support

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2024
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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