Opioid DependencyNCT06733649
Treatment Education for Perinatal Women and Their Community Support
A study testing substance abuse treatment education in people with Opioid Dependency, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Opioid Dependency
- What is being tested?
- substance abuse treatment education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2026to 5 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- perinatal women treated with agonist medication
- interest in study participation
- interest in community support:
- interest in study participation
Who cannot join
- perinatal women not treated with agonist medication
- not interested in study participation
- not interested in community support:
- not interested in study participation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Treatment Education for Pre- and Postpartum 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.
Read the 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
- Being tested
- substance abuse treatment education
- Keywords
- opioid dependence, perinatal women, social support
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
substance abuse treatment educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment education for perinatal women and the womens' community support | Experimental | Not described Receives: Other: substance abuse treatment education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women interested in study participation
Feasibility -- percentage of women interested in study participation
Measured: Immediately before session 1
Percentage of interested women who bring in community support to the education group
Acceptability -- proportion of interested women who bring in community support to the education group
Measured: Immediately before session 1
Secondary outcomes (1)
Knowledge as assessed by survey
Women and the womens' community support will complete a 10 question true / false test before and after the education session
Measured: Baseline, Immediately after session 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start6 Dec 2026 (estimated)
- Primary completion5 Dec 2027 (estimated)
- Study completion5 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependencyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Perinatal women and the woman's community support will receive one treatment education session.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kidorf, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733649
- Sponsor's protocol ID
- IRB00478467
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Education for Pre- and Postpartum Women and Their Community Support
- ClinicalTrials.gov ID
- NCT06733649
- Acronym / sponsor ID
- IRB00478467
- Conditions
- Opioid Dependency
- Keywords
- opioid dependence, perinatal women, social support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 6 Dec 2026 (estimated)
- Primary completion
- 5 Dec 2027 (estimated)
- Study completion
- 5 Dec 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Perinatal women and the woman's community support will receive one treatment education session.
| Arm | Type | Receives |
|---|---|---|
| Treatment education for perinatal women and the womens' community support | Experimental | Other: substance abuse treatment education |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- perinatal women treated with agonist medication
- interest in study participation
- interest in community support:
- interest in study participation
Key exclusion criteria (4 listed)
- perinatal women not treated with agonist medication
- not interested in study participation
- not interested in community support:
- not interested in study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| substance abuse treatment educationPerinatal 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. | Other | Treatment education for perinatal women and the womens' community support |
Primary outcome
Percentage of women interested in study participation
Time frame: Immediately before session 1
Feasibility -- percentage of women interested in study participation
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
1 secondary outcome
Knowledge as assessed by survey
Time frame: Baseline, Immediately after session 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Kidorf, Ph.D. principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing substance abuse treatment education in people with Opioid Dependency, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Kidorf, Ph.D. (410 550 0006, mkidorf@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women interested in study participation (time frame: Immediately before session 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.