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New therapy combo aims to keep women in opioid recovery

NCT ID NCT07115030

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tests a stepped care program called PCT+2HOPE for women with opioid use disorder who have also experienced intimate partner violence and PTSD symptoms. The program adds group and individual therapy to standard medication treatment. Researchers will see if it helps women stay in treatment longer and improves their mental health and recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral therapy (Present-Centered Therapy and Helping to Overcome PTSD through Empowerment)
What this could lead to
If successful, this could show that adding trauma-focused therapy to standard medication treatment helps more women stay in recovery from opioid use disorder.
What could go wrong
This is a behavioral intervention study, not a drug trial, so results may be modest. The study is still recruiting and outcomes depend on participant engagement and follow-up.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 532 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Woman; * Are ≥ 18 years old; * Receive MOUD treatment at one of the participating sites; * Have received MOUD for \>14 days to allow for initial stabilization; * Have initiated the current treatment episode within the past 12 months; * Experienced physical or psychological IPV in their lifetime; * Have at least moderate impairment in psychosocial functioning (on B-IPF) as a result of PTSD symptoms; * Available during the date/time of the intervention group * Able to read/understand English; and * Provide written informed consent. Exclusion Criteria: * Fail a capacity-to-consent questionnaire; * Have an unstable medical condition (e.g., hospitalization, planned surgery, newly starting chemotherapy, plans for palliative care) and/or unstable psychiatric illness (e.g., untreated psychosis) that would interfere with their ability to participate in study activities; * Will be unavailable for \>4 consecutive weeks during the study period (e.g., anticipated move, planned surgery); * Are unable to read/understand English; * Inability to provide at least one form of contact

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Conditions

The condition(s) this trial relates to.

combat disorder opiate dependence post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intimate partner violence (IPV) Opioid-use disorder Post traumatic stress disorder PTSD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Community Health Resources (CHR) Pathways Opiate Treatment Program

    NOT_YET_RECRUITING

    Enfield, Connecticut, 06082, United States

  • Liberation Programs

    RECRUITING

    Bridgeport, Connecticut, 06610, United States

  • The APT Foundation, Inc.

    RECRUITING

    West Haven, Connecticut, 06516, United States

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