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Collaborative Care for Opioid Use Disorder and Mental Health Conditions

N/A

Recruiting

Led By David Mandell, ScD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years and older

Agree to receive medication for opioid use disorder at the primary care site (the first line pharmacotherapy is buprenorphine-naloxone and the second line pharmacotherapy will include extended-release injectable naltrexone)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help refine and test a collaborative care model for patients with opioid use disorder and comorbid depression, anxiety, or post-traumatic stress disorder.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include those associated with medications used in opioid addiction such as buprenorphine-naloxone (nausea, headache, withdrawal symptoms) and extended-release injectable naltrexone (injection site reactions). Mental health interventions might also bring emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I agree to take medication for opioid addiction at my primary care provider.

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I agree to take medication for opioid addiction at my primary care provider.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in opioid use based on self-reported

Change in opioid use based on toxicology

Change in psychiatric symptoms - Anxiety

+2 more

Secondary study objectives

Change in Illicit use of other drugs besides opioids (e.g. benzodiazepines, cocaine)

Change in medication adherence

Rate of Mortality

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,077 Previous Clinical Trials

42,718,900 Total Patients Enrolled

Weill Medical College of Cornell UniversityOTHER

1,085 Previous Clinical Trials

1,146,137 Total Patients Enrolled

David Mandell, ScD3.834 ReviewsPrincipal Investigator - University of Pennsylvania

University of Pennsylvania

5Patient Review

Dr. Mandell is extremely knowledgeable and well-informed on the latest evidence-based practices. He was able to explain things to me in a way that I could understand. He is great with people, including children with special needs — he treats them just like he would anybody else. My other daughter, who is now 22, raves about Dr. Mandell. I am sure that she will take her children to him if she ever needs to.