Opioid Use DisorderNCT06641115
Integrated Treatment for Opioid Use Disorder and PTSD
A study testing HOPE Therapy in people with Opioid Use Disorder and Posttraumatic Stress Disorder (PTSD), run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid Use Disorder, Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- HOPE Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29403
Tanya C Saraiya, PhD, 8438762374, saraiya@musc.edu
About this study
Official title: Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder
This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.
Read the detailed description
Up to half of individuals with OUD have PTSD, but to date, there are no established evidence-based behavioral interventions that concurrently address OUD and PTSD symptoms. The proposed study directly addresses this major clinical gap by testing whether augmenting medications for OUD by testing an adapted, trauma-focused, integrated behavioral treatment for substance use disorders and co-occurring PTSD (i.e., Helping Opioid Use and PTSD with Exposure; HOPE) will enhance clinical outcomes. The investigators will test HOPE combined with medications for OUD (MOUD) versus MOUD-only in a randomized clinical trial among 76 individuals with OUD and PTSD to evaluate feasibility and preliminary efficacy in reducing opioid use and PTSD severity. Both conditions will also complete ecological momentary assessments (EMA) to assess for daily opioid use, craving, and PTSD symptoms. EMA will allow for the assessment of the associations between daily PTSD symptoms and opioid craving and use, which may then inform treatment development.
- Being tested
- HOPE Therapy
- Keywords
- Mental Health, Psychiatry, Substance Use, PTSD, Opioid Use, Therapy
- Medical subject headings
- Opioid-Related Disorders, Stress Disorders, Post-Traumatic, Psychological Well-Being, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPE TherapyBehavioural
Helping Opioid Use and PTSD with Exposure (HOPE) therapy is an integrated 10-12 week treatment for opioid use disorder and trauma/posttraumatic stress disorder
| Study group | Role | What they receive |
|---|---|---|
| HOPE Therapy | Experimental | Helping Opioid Use and PTSD with Exposure (HOPE) therapy is an integrated 10-12 week treatment for opioid use disorder and trauma/posttraumatic stress disorder Receives: Behavioral: HOPE Therapy |
| Treatment as Usual | No intervention | Participants take medications as prescribed and attend standard community substance use treatment services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Opioid Use
Opioid use (percent days using) as measured by urine drug screens
Measured: through study treatment completion, an average of 12 weeks
Change in Posttraumatic Stress Disorder Symptoms
Posttraumatic Stress Disorder symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual for Mental Disorders, 5th Edition or the CAPS-5. Total severity scores on this measure range from 0-80 with higher scores denoting more severe posttraumatic stress disorder symptoms.
Measured: through study treatment completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Mar 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Tanya Saraiya, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641115
- Sponsor's protocol ID
- Pro00138487
- Other IDs
- K23DA055209
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT06641115
- Acronym / sponsor ID
- Pro00138487
- Keywords
- Mental Health, Psychiatry, Substance Use, PTSD, Opioid Use, Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Oct 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.
This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.
Detailed description
Up to half of individuals with OUD have PTSD, but to date, there are no established evidence-based behavioral interventions that concurrently address OUD and PTSD symptoms. The proposed study directly addresses this major clinical gap by testing whether augmenting medications for OUD by testing an adapted, trauma-focused, integrated behavioral treatment for substance use disorders and co-occurring PTSD (i.e., Helping Opioid Use and PTSD with Exposure; HOPE) will enhance clinical outcomes. The investigators will test HOPE combined with medications for OUD (MOUD) versus MOUD-only in a randomized clinical trial among 76 individuals with OUD and PTSD to evaluate feasibility and preliminary efficacy in reducing opioid use and PTSD severity. Both conditions will also complete ecological momentary assessments (EMA) to assess for daily opioid use, craving, and PTSD symptoms. EMA will allow for the assessment of the associations between daily PTSD symptoms and opioid craving and use, which may then inform treatment development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOPE Therapy | Experimental | Behavioral: HOPE TherapyHelping Opioid Use and PTSD with Exposure (HOPE) therapy is an integrated 10-12 week treatment for opioid use disorder and trauma/posttraumatic stress disorder |
| Treatment as Usual | No intervention | –Participants take medications as prescribed and attend standard community substance use treatment services |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| HOPE TherapyHelping Opioid Use and PTSD with Exposure (HOPE) therapy is an integrated 10-12 week treatment for opioid use disorder and trauma/posttraumatic stress disorder | Behavioural | HOPE Therapy |
Primary outcome
Change in Opioid Use
Time frame: through study treatment completion, an average of 12 weeks
Opioid use (percent days using) as measured by urine drug screens
Change in Posttraumatic Stress Disorder Symptoms
Time frame: through study treatment completion, an average of 12 weeks
Posttraumatic Stress Disorder symptoms as measured by the Clinician Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual for Mental Disorders, 5th Edition or the CAPS-5. Total severity scores on this measure range from 0-80 with higher scores denoting more severe posttraumatic stress disorder symptoms.
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 28 Nov 2025.
- 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.
Tanya Saraiya, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOPE Therapy in people with Opioid Use Disorder and Posttraumatic Stress Disorder (PTSD), run by Medical University of South Carolina at 1 site in United States.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tanya C Saraiya, Ph.D. (8438762374, saraiya@musce.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Opioid Use (time frame: through study treatment completion, an average of 12 weeks). 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 28 Nov 2025.