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New HOPE therapy aims to tackle opioid addiction and PTSD together

NCT ID NCT06641115

Symptom relief Sponsor: Medical University of South Carolina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a therapy called HOPE for people who have both opioid use disorder and PTSD. Participants must already be on medication for opioid use disorder (like Suboxone or methadone). Over 10-12 weeks, they will attend therapy sessions and complete surveys to see if their opioid use and PTSD symptoms improve.

What this could mean

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

Active substance
HOPE therapy (behavioral therapy)
What this could lead to
If it works, this could provide an effective integrated therapy for people struggling with both opioid addiction and PTSD, potentially improving recovery outcomes.
What could go wrong
This is a small early-stage study with only 76 participants, so results may not apply to everyone. The therapy is intensive (10-12 weeks) and may not work for all individuals.

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 76 people

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

Started

Mar 2025

Expected to finish

Aug 2027

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 to 70 years

Sex

Anyone

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: * Any gender; any race or ethnicity; aged 18-70 years old. * English-speaking * Meet DSM-5 diagnostic criteria for OUD. * Meet DSM-5 diagnostic criteria for PTSD and have some memory of their index traumatic event. * Must be maintained on a stable dose of medication for OUD for at least 1 month. * Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 1 month before study initiation. Exclusion Criteria: * Participants presenting with psychiatric contraindications (e.g., unmanaged psychosis or mania, or bipolar) will be excluded and referred clinically. * Participants considered an immediate suicide risk, with current suicidal ideation and a plan of intent, or displaying other high-risk behaviors (i.e., MOUD refusal, risky fentanyl use, etc.), as determined by the PI and study team. These individuals will complete a safety plan and be referred for treatment. * Participants meeting DSM-5 criteria for a concurrent, non-opioid, substance use disorder and who report that the other substance is their primary substance of use. These participants will be referred clinically for treatment. * Participants enrolled in ongoing evidence-based psychotherapy for substance use disorders or PTSD outside of medications for OUD and standard psychotherapy groups in treatment programs. * Medical problems requiring immediate and intensive treatment, such as unstable or symptomatic end stage liver disease.

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Conditions

The condition(s) this trial relates to.

opiate dependence post-traumatic stress disorder Psychological Well-Being substance-related disorder

As listed by the trial registrant

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

Opioid use disorder Posttraumatic 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

    1 site. 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

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29403, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.