Collaborative Care for Opioid Use Disorder and Mental Health Conditions

Overseen By Tiffany DeMenna, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Opioid use disorder medications

Disqualifiers: Acutely suicidal, Manic, Psychotic, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

567 Participants Needed

Trial Summary

What is the purpose of this trial?

Collaborative care for mental health is increasingly common, but most primary care practices have not embraced similar models for opioid use disorder (OUD). This study will refine and test a collaborative care model for patients with opioid use disorder (OUD) and depression, anxiety or post-traumatic stress disorder (PTSD) in primary care. We also will examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must agree to receive medication for opioid use disorder at the primary care site.

What data supports the effectiveness of this treatment for opioid use disorder and mental health conditions?

Collaborative care, which involves a team-based approach to treatment, has shown promise in improving access to care and outcomes for people with opioid use disorder (OUD) in primary care settings. The PROUD trial suggests that using a collaborative care model can increase the number of days patients receive medication for OUD and reduce the need for acute healthcare services. ^{1 2 3 4 5}

Is collaborative care for opioid use disorder and mental health conditions safe for humans?

The research does not provide specific safety data for collaborative care in treating opioid use disorder and mental health conditions, but it is generally used to improve treatment access and quality in primary care settings. ^{1 2 5 6 7}

How is the Collaborative Care treatment for opioid use disorder and mental health conditions different from other treatments?

This treatment is unique because it uses a team-based approach to address both opioid use disorder and mental health conditions together, which is not commonly done in standard treatments. It aims to improve access to care and treatment outcomes by coordinating services across different healthcare providers. ^{1 2 5 7 8}

Research Team

David Mandell, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 with opioid use disorder and a mental health condition like depression, anxiety, or PTSD. Participants must have been diagnosed or treated for OUD within the last year, speak English, consent to treatment at the primary care site using buprenorphine-naloxone or naltrexone injections, and be willing to give informed consent. Those acutely suicidal, manic, psychotic or without a phone are excluded.

Inclusion Criteria

able to communicate in a language that is understood by most people.

I have been diagnosed with depression, anxiety, or PTSD.

Willing to give informed consent

Exclusion Criteria

Lack of a phone.

Acutely suicidal and needs immediate hospitalization, manic or psychotic (patients will not be randomized and PI or study physician covering for PI will be notified immediately)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive collaborative care for OUD and mental health conditions, including pharmacotherapy and care management

6 months

Monthly visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Augmented Usual Care
• Collaborative Care for Opioid Use Disorders and Mental Health Conditions
• Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists

Trial Overview The study tests a collaborative care model in primary care for patients with both opioid use disorder (OUD) and certain mental health conditions. It compares standard care against this model plus support from certified recovery specialists. The goal is to refine care approaches for OUD alongside depression, anxiety disorders or PTSD.

Participant Groups

Group I: Collaborative Care + Certified Recovery Specialist (CC+) Experimental Treatment 1 Intervention

In addition to the collaborative care model described above, patients in the CC+ condition will have access to a Certified Recovery Specialist (CRS) to assist with treatment engagement and retention. A CRS is a person in the community who is in recovery and may share similar experiences and barriers that participants have faced. They will work with participants as a peer to help them coordinate information and needs with their providers. The CRS will take participants to their PCP appointments and any other appointments that they may have to help them engage and stay in care to remain healthy. They will also provide education and help participants work on their recovery goals. They will identify and support linkages to community resources and help participants identify barriers to full participation in their recovery and develop strategies to overcome those barriers.

Group II: Collaborative Care (CC) Experimental Treatment 1 Intervention

CC condition includes the following elements: 1. Personnel trained to assist with scheduling, reminders and referrals; 2. PCP trained and waivered to provide evidence-based pharmacotherapy for OUD; 3. Addictions psychiatrist with collaborative care expertise to provide treatment consultation and supervision in both OUD and mental health issues; 4. A care manager trained in evidence-based interventions for individuals with OUD and psychiatric disorders, who provides care in the primary care practice as part of the collaborative care team; 5. Measurement-guided care and treat-to-target practices, using validated measures of substance use, depression, anxiety as well as measures of adherence and side effects; 6. Electronic and in-person systematic communication regarding patient care among team members, facilitated by the electronic health record; and 7. Shared patient-provider decision making.

Group III: Augmented Usual Care (AUC) Active Control 1 Intervention

If not already waivered, PCPs will be trained and waivered to treat OUD with medications. Almost all practices have hired mental health clinicians, equivalent to the care managers in the investigators' collaborative care model, to treat mild and moderate depression and anxiety. These clinicians typically are licensed clinical social workers; a few are nurses or psychologists. No care managers have received systematic training in treating patients with OUD. The clinicians will retain their role and continue to treat and monitor patients with mental health conditions in these practices. Other than that, the research team will provide no support to the PCP or practice staff. However, an addiction psychiatrist is available for consultation for OUD. Patients are informed that the primary care practice provides both OUD and mental health treatment and are referred back to their provider for referral or to schedule care. A list of available community resources are available to the patient.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Findings from Research

The study developed a new collaborative care model called CLARO, specifically designed to improve treatment for patients with co-occurring opioid use disorders (OUD) and mental health issues like depression and PTSD, using input from a diverse team of stakeholders.

Twelve key adaptations were made to the traditional collaborative care approach, including the use of community health workers and modified training protocols, aimed at enhancing the model's effectiveness and acceptability in low-resource healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. Osilla, KC., Dopp, AR., Watkins, KE., et al.[2022]

The PROUD trial is testing a collaborative care model in primary care settings to improve treatment access for opioid use disorder (OUD), involving over 170,000 patients across six health care systems.

The trial aims to measure the effectiveness of this model by comparing the number of days patients receive medication for OUD and the reduction in acute health care utilization, providing valuable insights for future OUD management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. Campbell, CI., Saxon, AJ., Boudreau, DM., et al.[2022]

The COACHH program emphasizes the importance of building trusting relationships with pregnant and postpartum women with opioid use disorder (OUD) to enhance patient engagement and effectively address their complex needs.

A diverse care team is essential for providing specialized, time-intensive support, but challenges such as low referral rates and difficulties in measuring outcomes highlight the need for tailored care approaches for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinating Outpatient Care for Pregnant and Postpartum Women with Opioid Use Disorder: Implications from the COACHH Program. Hodgins, FE., Lang, JM., Malseptic, GG., et al.[2020]

A collaborative care model for treating pregnant patients with opioid use disorder using buprenorphine was shown to be feasible, with 93.8% of pregnancies continuing treatment until delivery.

Most infants (80%) required NICU admission for monitoring or treatment of neonatal abstinence syndrome, highlighting the need for ongoing research to enhance outcomes for mothers and their babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of collaborative care treatment of opioid use disorders with buprenorphine during pregnancy. Mittal, L., Suzuki, J.[2018]

A program in Maine successfully created collaboratives of mental health and substance abuse providers, improving coordinated treatment for individuals with both psychiatric and substance use disorders.

Surveys conducted one and two years after the program's establishment showed significant increases in interagency referrals, joint client assessments, and collaborative training efforts among providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interagency collaboration in services for people with co-occurring mental illness and substance use disorder. Ridgely, MS., Lambert, D., Goodman, A., et al.[2006]

References

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

Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO): process of adapting collaborative care for co-occurring opioid use and mental disorders. [2022]

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

Collaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol. [2023]

3. England pubmed.ncbi.nlm.nih.gov

PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. [2022]

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

Coordinating Outpatient Care for Pregnant and Postpartum Women with Opioid Use Disorder: Implications from the COACHH Program. [2020]

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

Clinician commentary on adapting psychotherapy in collaborative care for treating opioid use disorder and co-occurring psychiatric conditions in primary care. [2023]

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

Feasibility of collaborative care treatment of opioid use disorders with buprenorphine during pregnancy. [2018]

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

Interagency collaboration in services for people with co-occurring mental illness and substance use disorder. [2006]

8. Ireland pubmed.ncbi.nlm.nih.gov

Co-occurring substance use and mental disorders among adults with opioid use disorder. [2019]