PCT+2HOPE for Opioid Use Disorder

(STRONGER Trial)

Not yet recruiting at 2 trial locations

Overseen By Ashley Clayton, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Must be taking: MOUD

Disqualifiers: Unstable medical, psychiatric illness, others

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

Compensation: Varies

Number of Visits: 8

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach, PCT+2HOPE, for women with opioid use disorder (OUD) who have experienced intimate partner violence (IPV). The goal is to determine if this approach helps participants remain in their medication treatment longer than usual care. The trial also examines the treatment's effectiveness in addressing trauma-related issues, substance use, and empowerment. Women who have been in medication treatment for opioid use for at least two weeks and have experienced IPV may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to more effective treatments for OUD and IPV.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on women already receiving medication for opioid use disorder, so you may be able to continue your current treatment.

What prior data suggests that the PCT+2HOPE model is safe for women with opioid use disorder?

Research has shown that the PCT+2HOPE program builds on two existing therapies: Present-Centered Therapy (PCT+) and Helping to Overcome PTSD through Empowerment (HOPE). These therapies have been specifically adjusted for women dealing with opioid addiction. Designed to be supportive, they have generally been well-received in the past.

While specific data on side effects for PCT+2HOPE in this trial is not available, the use of well-established therapies suggests it should be safe. This trial is in a phase called "Not Applicable," which usually focuses on treatment efficacy and application rather than initial safety testing. This typically indicates that earlier studies or similar situations have considered the treatment safe.

Overall, based on existing knowledge of PCT+ and HOPE, PCT+2HOPE is expected to be a safe choice for participants, with a low likelihood of negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PCT+2HOPE approach for opioid use disorder because it uniquely combines group therapy and individual counseling tailored to women with PTSD and intimate partner abuse experiences. Unlike standard treatments that focus solely on medication-assisted therapy, PCT+2HOPE addresses the psychosocial challenges stemming from PTSD, potentially improving overall treatment outcomes. The program's flexibility to step up care with the HOPE sessions based on individual needs represents a personalized approach, aiming to enhance retention and effectiveness in opioid use disorder treatment.

What evidence suggests that PCT+2HOPE might be an effective treatment for opioid use disorder?

Studies have shown that PCT+2HOPE could assist women with opioid use disorder (OUD) who have experienced intimate partner violence. In this trial, participants in the PCT+2HOPE arm will first receive Present-Centered Therapy (PCT+) to manage PTSD-related issues in daily life. If symptoms persist, the therapy progresses to Helping to Overcome PTSD through Empowerment (HOPE), offering more personalized support. Early research suggests these therapies can help women remain in their medication treatment for OUD by addressing trauma and enhancing mental health. This approach aims to keep more women engaged in their OUD treatment, which is crucial for recovery. ^{2 4 5 6 7}

Who Is on the Research Team?

Tami Sullivan, PhD

Principal Investigator

Yale University

E. Jennifer Edelman, MD, MHS, AAHIVS

Principal Investigator

Yale University

Dawn Johnson, PhD

Principal Investigator

The University of Akron

Are You a Good Fit for This Trial?

This trial is for women with opioid use disorder who have experienced intimate partner violence. Participants should be engaged in community-based medication treatment for opioid use and may also suffer from PTSD or related trauma.

Inclusion Criteria

I started my current treatment less than a year ago.

Available during the date/time of the intervention group

Able to read and understand English

Exclusion Criteria

Have an unstable medical condition or unstable psychiatric illness that would interfere with study activities

Unavailable for more than 4 consecutive weeks during the study period

Unable to read and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PCT+ via eight 1-hour group sessions over 12 weeks, followed by HOPE for those who meet criteria

26 weeks

8 group sessions, 10 individual sessions

Follow-up

Participants are monitored for retention in MOUD treatment and secondary outcomes such as PTSD-related impairment, depression, and opioid use

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PCT+2HOPE

Trial Overview The study tests a new care model called 'PCT+2HOPE' against usual treatments. It combines Present-Centered Therapy (PCT+) with stepped care, escalating to Helping Overcome PTSD through Empowerment (HOPE) based on the severity of PTSD-related impairment.

How Is the Trial Designed?

Group I: PCT+2HOPE Experimental Treatment 1 Intervention

During the first 12 weeks, participants will be offered PCT+ via eight 1-hour group sessions facilitated by a trained counselor ("facilitator") at the treatment program where they receive MOUD. The purpose of this group is to help participants address problems in their daily lives that arise from PTSD-related impairment in psychosocial functioning. After 12 weeks, participants who meet any of the following criteria will be "stepped up" to HOPE: 1) are not retained in MOUD treatment or 2) have moderate or higher impairment in PTSD-related psychosocial functioning. Participants who are "stepped up" will be offered 10 1-hour individual sessions over the next 14 weeks. HOPE is an individual counseling program designed for women in treatment for their opioid use, who have experienced abuse from an intimate partner and are experiencing PTSD-related impairment in psychosocial functioning.

Group II: Treatment as Usual Active Control 1 Intervention

Participants will be provided with a list of community resources and a referral to a local domestic violence service provider that can help address experiences of relationship strain with an intimate or romantic partner.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

2. withpower.com withpower.com/trial/phase-opioid-related-disorders-8-2025-07b75

PCT+2HOPE for Opioid Use Disorder (STRONGER Trial) We will explore the extent to which the effectiveness of PCT+2HOPE vs. treatment as usual differs based on access to basic needs. We will also conduct an ...

3. reporter.nih.gov reporter.nih.gov/project-details/10812139

1R61DA059895-01 We will explore, prepare for, and then implement a randomized controlled trial to evaluate PCT+2HOPE versus treatment as usual while collecting data relevant ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03985163

Patient Reported Outcomes for Opioid Use Disorder The goal of the project is to build a clinical data research infrastructure that will begin to enhance capacity to use electronic health record (EHR) data and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9543602/

The opioid use disorder core outcomes set (OUD–COS) for ... The opioid use disorder core outcomes set (OUD–COS) for treatment research: findings from a Delphi consensus study

6. reporter.nih.gov reporter.nih.gov/project-details/11371675

RePORT RePORTER - National Institutes of Health (NIH) | We will explore, prepare for, and then implement a randomized controlled trial to evaluate PCT+2HOPE versus treatment as usual while collecting data relevant ...

7. medicine.yale.edu medicine.yale.edu/news-article/nida-invests-nearly-dollar7m-to-address-the-opioid-crisis-among-women-who-experience-intimate-partner-violence/

NIDA Invests Nearly $7M to Address the Opioid Crisis Among ... In this study, and after conducting formative work, PCT+ and HOPE will be packaged as a stepped care model to create PCT+2HOPE. PCT+ focuses on ...