Treatment Education for Perinatal Women and Their Community Support

NCT ID: NCT06733649

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-06
• Study Completion Date: 2027-12-05

Brief Summary

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.

Detailed Description

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.

Conditions

Opioid Dependency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment education for perinatal women and the womens' community support

Group Type: EXPERIMENTAL

substance abuse treatment education

Intervention Type: 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.

Interventions

substance abuse treatment education

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kidorf, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Central Contacts

Michael Kidorf, Ph.D.

Role: CONTACT

mkidorf@jhmi.edu

410 550 0006

Denis Antoine, MD

Role: CONTACT

antoine@jhmi.edu

410 550 7843

Other Identifiers

IRB00478467

Identifier Type: -

Identifier Source: org_study_id