HOPE Therapy for Opioid Use Disorder and PTSD

Overseen By Tanya C Saraiya, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must be taking: Medications for OUD

Disqualifiers: Unmanaged psychosis, Bipolar, Suicide risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10-12 weeks

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy called HOPE for individuals with both opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). The goal is to determine if this therapy can improve symptoms when combined with medications such as suboxone, naltrexone, or methadone. Participants will attend 10-12 weeks of therapy and complete surveys about their experiences. It suits English-speaking individuals who have been on stable OUD medication for at least a month and have PTSD from a specific traumatic event they remember. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current medications for opioid use disorder and any psychotropic medications for at least one month before starting the study.

What prior data suggests that HOPE Therapy is safe for individuals with opioid use disorder and PTSD?

Research has shown that HOPE Therapy, a treatment for opioid addiction and posttraumatic stress disorder (PTSD), is generally easy for people to handle. In one study, 83.3% of participants completed the therapy successfully. This high completion rate suggests that most people find the treatment manageable. Additionally, participants reported increased satisfaction with the therapy over time. No serious side effects were reported, indicating a positive safety profile. This therapy aims to help individuals with both opioid addiction and PTSD, enhancing their overall well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

HOPE Therapy is unique because it combines treatment for opioid use disorder with therapy for PTSD in a single, integrated approach. Unlike standard treatments that often address these conditions separately—such as using medications like methadone or buprenorphine for opioid addiction and cognitive behavioral therapy for PTSD—HOPE Therapy blends these elements together, potentially enhancing effectiveness by simultaneously targeting both issues. Researchers are excited about this innovative approach because it could offer a more comprehensive and efficient solution for individuals facing the dual challenges of opioid dependence and trauma.

What evidence suggests that HOPE Therapy might be an effective treatment for opioid use disorder and PTSD?

Research has shown that HOPE Therapy, which participants in this trial may receive, could help treat opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). In earlier studies, participants reported increased satisfaction over time, and 83.3% completed the therapy successfully. Patients also experienced improvements in PTSD symptoms, felt less depressed, and used fewer illegal drugs. These results suggest that HOPE Therapy may effectively support people dealing with OUD and PTSD. ^{1 3 5 6 7}

Who Is on the Research Team?

Tanya Saraiya, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for individuals who are currently on medications like suboxone, naltrexone, or methadone to manage opioid use disorder and also have posttraumatic stress disorder (PTSD). Participants will undergo a therapy called HOPE over 10-12 weeks and complete surveys.

Inclusion Criteria

English-speaking

Meet DSM-5 diagnostic criteria for OUD

I have been on a stable dose of my mental health medication for at least 1 month.

Exclusion Criteria

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

I am currently in psychotherapy for substance use or PTSD, not including standard groups or medication for opioid use.

I have a substance use problem that isn't related to opioids, and it's my main issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HOPE therapy combined with medications for opioid use disorder over 10-12 weeks

10-12 weeks

Weekly therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HOPE Therapy

Trial Overview The study is testing HOPE Therapy as an intervention for those suffering from both opioid use disorder and PTSD. The aim is to see if this therapy can help improve the conditions of participants over the course of approximately three months.

How Is the Trial Designed?

Group I: HOPE Therapy Experimental Treatment 1 Intervention

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

Group II: Treatment as Usual Active Control 1 Intervention

Participants take medications as prescribed and attend standard community substance use treatment services

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study of 89 adults seeking buprenorphine treatment for opioid use disorder (OUD) in rural Vermont, 31% reported a history of posttraumatic stress disorder (PTSD), highlighting the prevalence of PTSD among this population.

Individuals with PTSD were less likely to have received prior OUD treatment despite having better access to healthcare resources, and they experienced more severe psychiatric and medical issues, indicating a need for targeted interventions to support this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder in individuals seeking treatment for opioid use disorder in Vermont. Peck, KR., Moxley-Kelly, N., Badger, GJ., et al.[2022]

A pilot study involving 30 adults with co-occurring PTSD and opioid use disorder showed that providing financial incentives for attending Prolonged Exposure (PE) therapy significantly increased attendance rates (87% vs. 35%) compared to standard PE therapy.

Participants receiving PE with financial incentives also experienced greater reductions in PTSD symptoms and had lower rates of opioid use, with 0% testing positive for opioids compared to 22% in the treatment as usual group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for PTSD in individuals with opioid use disorder: A randomized pilot study. Peck, KR., Badger, GJ., Cole, R., et al.[2023]

Women with opioid use disorder (OUD) expressed significant interest in technology-delivered, trauma-informed treatments, indicating a need for innovative approaches to address their unique challenges, including high PTSD symptoms and trauma histories.

Both clients and providers emphasized that any technology-based intervention should complement, rather than replace, traditional face-to-face therapy, highlighting the importance of maintaining personal connections in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on trauma and the design of a technology-based trauma-informed intervention for women receiving medications for addiction treatment in community-based settings. Saraiya, TC., Swarbrick, M., Franklin, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12292416/

Helping Opioid Use Disorder and PTSD with Exposure (HOPE) Client satisfaction increased throughout the study (B = 0.18, SE = 0.08, p = 0.02), and 83.3% of participants completed the therapy and follow- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743521003868

Posttraumatic stress disorder in individuals seeking ... This study examined the characteristics associated with a history of PTSD among a sample of individuals seeking buprenorphine treatment for OUD in Vermont.

3. withpower.com withpower.com/trial/phase-stress-disorders-traumatic-2025-6c6be

HOPE Therapy for Opioid Use Disorder and PTSD In a study of 89 adults seeking buprenorphine treatment for opioid use disorder (OUD) in rural Vermont, 31% reported a history of posttraumatic stress disorder ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40723658/

Helping Opioid Use Disorder and PTSD with Exposure (HOPE) Client satisfaction increased throughout the study (B = 0.18, SE = 0.08, p = 0.02), and 83.3% of participants completed the therapy and follow- ...

5. ptsd.va.gov ptsd.va.gov/publications/rq_docs/V30N1.pdf

Opioid Use Among Individuals with Posttraumatic Stress ... The treatment outcomes measures included. PTSD symptoms, depressive symptoms, and illicit drug use. Ten of the 12 study patients completed treatment. PTSD ...

6. researchgate.net researchgate.net/publication/393284668_Helping_Opioid_Use_Disorder_and_PTSD_with_Exposure_HOPE_An_Open-Label_Pilot_Study_of_a_Trauma-Focused_Integrated_Therapy_for_OUDPTSD

Helping Opioid Use Disorder and PTSD with Exposure ... Client satisfaction increased throughout the study (B = 0.18, SE = 0.08, p = 0.02), and 83.3% of participants completed the therapy and follow- ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0887618521001377

Efficacy and acceptability of interventions for co-occurring ... All active treatments reduced PTSD and substance use disorder (SUD) outcomes. •. Trauma-focused treatments reduced PTSD more than all other comparators. •.