Trauma-Informed Case Management for Opioid Use Disorder

Overseen By Olga Rivera-Galati

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Abenaa Jones, Ph.D.

Must be taking: MOUD

Disqualifiers: Not female, Under 18, others

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

Compensation: Varies

Number of Visits: 15

Duration: 6 months

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Opioid-related overdose deaths and incarceration rates have skyrocketed and have disproportionately affected women. Despite having a higher burden of substance use disorders and HIV/AIDS than criminal justice-involved (CJI) men, CJI women are less likely to have access to substance use and HIV treatment. The planned research aims to improve how women in the criminal justice system connect to and stay in drug treatment. This will be done by creating and putting into practice a well-researched program specifically designed for women, considering their experiences with trauma. The program incorporates several best practices in substance use treatment such as the use of Certified Peer Recovery Specialists (CRS) as needed social support, assisting women who do not have stable housing in finding housing, overdose response training, and reducing known barriers to women by assisting with transportation and childcare. In addition, half of the women will be randomly selected to participate in a 12-session trauma support group led by CRS which uses the evidence-based curriculum, Beyond Trauma, which was specifically designed for women who use drugs. The aforementioned components are rarely offered in tandem with substance use treatment, and as such, this research is assessing if having this comprehensive program is linked with better substance use and social outcomes. The overall goal is to reduce the problem of opioid addiction and overdoses among women who have recently been involved in the criminal justice system and to reduce the barriers to opioid addiction treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on women interested in starting or continuing medication-assisted treatment for opioid use, so it's best to discuss your current medications with the trial coordinators.

What data supports the effectiveness of the treatment Trauma-Informed Case Management for Opioid Use Disorder?

Research shows that trauma-informed care, which considers the impact of trauma on individuals, can lead to better outcomes in drug abstinence, mental health, and PTSD symptoms for women in substance abuse treatment. This approach has been beneficial across different racial and ethnic groups. ^{1 2 3 4 5}

Is trauma-informed case management for opioid use disorder safe for humans?

Research indicates that trauma-informed interventions, like Seeking Safety, are generally safe for women with substance use disorders, with minimal adverse effects reported during treatment. ^{5 6 7 8 9}

How is trauma-informed case management for opioid use disorder different from other treatments?

This treatment is unique because it specifically addresses the trauma that women who use drugs often experience, using principles like trauma awareness, safety, and collaboration to improve care and access to services, which are not typically the focus of standard substance use disorder treatments. ^{3 5 10 11 12}

Research Team

Abenaa Jones, Ph.D.

Principal Investigator

Penn State University

Eligibility Criteria

This trial is for women with opioid use disorder who have been involved in the criminal justice system. It aims to help them connect and stay in drug treatment by providing comprehensive support, including housing assistance, overdose training, and help with transportation and childcare.

Inclusion Criteria

I am considering or currently in a medication-based treatment for opioid use and need more support.

Use opioids illicitly

I am female.

Exclusion Criteria

No arrests, probation or parole, nor released from a jail or prison within the past 12 months

Do not use opioids illicitly

Not a Pennsylvania resident or no intention to remain in or near Harrisburg/Carlisle/York or Lancaster areas for the duration of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive case management using Certified Peer Recovery Specialists and may participate in a 12-session trauma support group

6 months

12 sessions (in-person)

Follow-up

Participants are monitored for substance use outcomes and retention in the intervention

6 months

3 visits (in-person)

Treatment Details

Interventions

• CRS Only Intervention
• Trauma-informed case management for women who use drugs

Trial Overview The study tests a program combining trauma-informed case management with peer recovery support. Women will either receive standard care or participate in a special 12-session trauma support group using an evidence-based curriculum designed for their needs.

Participant Groups

Group I: Case management using certified recovery specialists + Trauma Support Group Experimental Treatment 1 Intervention

Includes all the components in the comparative arm and a 12-session trauma support group led by CRS, which uses the evidence-based curriculum, Beyond Trauma, which was specifically designed for women who use drugs.

Group II: Case management using certified recovery specialists Active Control 2 Interventions

The arm incorporates several best practices in substance use treatment such as the use of Certified Peer Recovery Specialists (CRS) as needed social support, assisting women who do not have stable housing in finding housing, overdose response training, and reducing known barriers to women by assisting with transportation and childcare.

Who Is Running the Clinical Trial?

Abenaa Jones, Ph.D.

Lead Sponsor

Trials

1

Recruited

50+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Among 77 women with PTSD and substance dependence, there was high overall lifetime treatment utilization, but a notable subgroup reported no treatment exposure, highlighting gaps in care.

While most current treatments focused on substance abuse, over 80% of participants preferred combined or PTSD-only treatments, indicating a mismatch between available options and patient preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment utilization by women with PTSD and substance dependence. Najavits, LM., Sullivan, TP., Schmitz, M., et al.[2018]

The study analyzed data from 353 women with co-occurring substance use disorder (SUD) and post-traumatic stress disorder (PTSD) to identify three distinct patterns of substance use over a year after treatment: low use, high use, and moderate use, highlighting the complexity of recovery trajectories.

Improvement in PTSD severity was linked to specific substance use patterns, but the trauma-informed treatment did not significantly influence these trajectories, suggesting that while trauma-informed care is important, other factors like SUD severity and after-care efforts also play crucial roles in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways to change: Use trajectories following trauma-informed treatment of women with co-occurring post-traumatic stress disorder and substance use disorders. López-Castro, T., Hu, MC., Papini, S., et al.[2020]

A one-day training program for substance use disorder professionals significantly increased the rate of inquiries about physical abuse by 18% in the six months following the training, indicating its effectiveness in enhancing trauma inquiry practices.

However, the training did not improve inquiries about sexual abuse, emotional abuse, or neglect, suggesting that a longer training duration or additional support may be necessary to address these areas effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning How to Ask - Does a one-day training increase trauma inquiry in routine substance use disorder practice? Results of a cluster-randomized controlled trial. Lotzin, A., Buth, S., Sehner, S., et al.[2020]

Women receiving integrated trauma-informed services in substance abuse treatment showed significantly better outcomes in drug abstinence rates and reductions in mental health and PTSD symptoms at 6 and 12 months compared to those in the comparison group.

The integrated services were beneficial across various racial/ethnic groups, although some differences in the effectiveness of the intervention were noted, particularly in improving addiction severity and mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of integrated trauma treatment on outcomes in a racially/ethnically diverse sample of women in urban community-based substance abuse treatment. Amaro, H., Dai, J., Arévalo, S., et al.[2022]

Women who use drugs often face high rates of trauma, which can hinder their access to substance use and harm reduction services, highlighting the need for trauma-informed practices in research and clinical care.

Applying the four principles of trauma-informed practice—awareness of trauma, safety and trust, collaborative choice, and strengths-based approaches—can enhance the inclusion and safety of women who use drugs in substance use research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research With Women Who Use Drugs: Applying a Trauma-informed Framework. Robinson, K., Ickowicz, S.[2023]

In a study involving 353 women in substance abuse treatment, the integrated PTSD treatment (Seeking Safety) did not result in significantly more adverse events compared to a non-trauma-focused intervention (Women's Health Education), indicating that it is safe to implement PTSD treatment in these settings.

Both interventions had low rates of adverse events (9.6% for Seeking Safety and 7.2% for Women's Health Education), suggesting that addressing PTSD in substance abuse programs does not worsen psychiatric or substance use symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. Killeen, T., Hien, D., Campbell, A., et al.[2021]

The condensed version of the Seeking Safety intervention, consisting of six sessions, effectively reduced sexual-abuse-related trauma symptoms in women undergoing residential chemical dependence treatment, compared to standard treatment.

However, this condensed intervention did not show a significant advantage in reducing overall trauma symptoms or relapse rates 30 days post-treatment, indicating that while it may help with specific symptoms, it may not be sufficient for broader outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of a condensed Seeking Safety intervention for women in residential chemical dependence treatment at 30 days posttreatment. Ghee, AC., Bolling, LC., Johnson, CS.[2015]

The study aims to evaluate the efficacy of the Seeking Safety program, an integrated treatment for PTSD and substance use disorder (SUD), in a Dutch outpatient population through a randomized controlled trial involving 12 group sessions.

It is expected that participants receiving Seeking Safety will show greater improvements in substance use severity and lower drop-out rates compared to those receiving Cognitive Behavioral Therapy (CBT), with assessments conducted at the start, end, and six months after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial. Kok, T., de Haan, HA., van der Meer, M., et al.[2021]

A study of 851 women with substance use disorders (SUDs) who are homeless or near homeless found that 100% reported experiencing at least one type of trauma in their lifetime, with 75.3% having faced five to seven different types of trauma.

The high prevalence and emotional severity of trauma experiences among these women highlight the urgent need for trauma-informed care in treatment settings to address their complex mental health and substance use needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma Experience Among Women Who Have Substance Use Disorders and are Homeless or Near Homeless. Greene, A., Korchmaros, JD., Frank, F.[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]

Implementing routine systematic screening for PTSD in substance use disorder (SUD) clinics is crucial, as many patients with SUD are often underdiagnosed for PTSD, which can significantly impact their treatment outcomes.

The article emphasizes the importance of addressing shame sensitivity as a key factor in trauma-informed care, suggesting that countershaming strategies can enhance the effectiveness of interventions for patients with comorbid PTSD and SUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Considerations for Treating Comorbid Posttraumatic Stress Disorder in the Addictions Clinic: Approaches to Clinical Care, Leadership, and Alleviating Shame. Israel, B., Wiprovnick, AE., Belcher, AM., et al.[2022]

Traumatic life experiences can create a neurobiological vulnerability that increases the risk of developing substance use disorders (SUDs), highlighting the importance of understanding trauma in treatment.

Implementing trauma-informed care in SUD treatment improves patient experiences and retention, suggesting that addressing trauma and stigma can lead to better outcomes for individuals with SUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Necessity of a Trauma-Informed Paradigm in Substance Use Disorder Services. Bartholow, LAM., Huffman, RT.[2023]

References

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

Treatment utilization by women with PTSD and substance dependence. [2018]

2. Australia pubmed.ncbi.nlm.nih.gov

Pathways to change: Use trajectories following trauma-informed treatment of women with co-occurring post-traumatic stress disorder and substance use disorders. [2020]

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

Learning How to Ask - Does a one-day training increase trauma inquiry in routine substance use disorder practice? Results of a cluster-randomized controlled trial. [2020]

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

Effects of integrated trauma treatment on outcomes in a racially/ethnically diverse sample of women in urban community-based substance abuse treatment. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Research With Women Who Use Drugs: Applying a Trauma-informed Framework. [2023]

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

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. [2021]

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

The efficacy of a condensed Seeking Safety intervention for women in residential chemical dependence treatment at 30 days posttreatment. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial. [2021]

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

Trauma Experience Among Women Who Have Substance Use Disorders and are Homeless or Near Homeless. [2023]

10. 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]

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

Practical Considerations for Treating Comorbid Posttraumatic Stress Disorder in the Addictions Clinic: Approaches to Clinical Care, Leadership, and Alleviating Shame. [2022]

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

The Necessity of a Trauma-Informed Paradigm in Substance Use Disorder Services. [2023]