Collaborative Care for Opioid Use Disorder and Mental Health Conditions

Recruiting in Palo Alto (17 mi)

Overseen byDavid Mandell, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

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.

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

See 9 more

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)

Treatment Details

Interventions

Augmented Usual Care (Behavioral Intervention)
Collaborative Care for Opioid Use Disorders and Mental Health Conditions (Behavioral Intervention)
Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists (Behavioral Intervention)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Active Control

Group I: Collaborative Care + Certified Recovery Specialist (CC+)Experimental Treatment1 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 Treatment1 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 Control1 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.