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

Trial Summary

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 data supports the effectiveness of HOPE Therapy for treating opioid use disorder and PTSD?

Research shows that a modified version of prolonged exposure therapy, which is similar to HOPE Therapy, led to significant reductions in PTSD symptoms, anxiety, and depression in people with opioid use disorder. This suggests that HOPE Therapy might also be effective for these conditions. ^{1 2 3 4 5}

How is HOPE Therapy different from other treatments for opioid use disorder and PTSD?

HOPE Therapy is unique because it combines elements of prolonged exposure therapy, which is effective for PTSD, with strategies to improve therapy attendance among individuals with opioid use disorder. This approach addresses both PTSD symptoms and the challenges of maintaining consistent treatment for opioid use disorder. ^{1 3 5 6 7}

What is the purpose of this trial?

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.

Research Team

Tanya Saraiya, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Prolonged exposure therapy for PTSD in individuals with opioid use disorder: A randomized pilot study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder in individuals seeking treatment for opioid use disorder in Vermont. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Posttraumatic stress disorder in opioid agonist therapy: A review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

The impact of post-traumatic stress disorder on treatment outcomes for heroin dependence. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Adults with Comorbid Posttraumatic Stress Disorder, Alcohol Use Disorder, and Opioid Use Disorder: The Effectiveness of Modified Prolonged Exposure. [2019]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Neurocircuitry basis of the opioid use disorder-post-traumatic stress disorder comorbid state: conceptual analyses using a dimensional framework. [2022]