The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions

NAActive, not recruitingINTERVENTIONAL
Enrollment

567

Participants

Timeline

Start Date

December 15, 2020

Primary Completion Date

March 28, 2025

Study Completion Date

February 28, 2026

Conditions
Opioid-use DisorderMental Health Conditions
Interventions
BEHAVIORAL

Collaborative Care for Opioid Use Disorders and Mental Health Conditions

CC is delivered using the investigators' Foundations for Integrated Care model. The first line pharmacotherapy is buprenorphine-naloxone. The second line pharmacotherapy included is extended-release injectable naltrexone. Pharmacotherapy is accompanied by brief problem-solving therapy, cognitive-behavioral therapy, and/or motivational interviewing. The primary care physician, in consultation with the addictions psychiatrist and care manager, also will provide psychotropic medications for psychiatric disorders. In-person and telephone visits consist of the care manager carrying out intervention activities over 6 months. Visits are at baseline (90-minute intake appointment), home or office induction when in moderate opiate withdrawal if buprenorphine is prescribed, twice a week for two weeks with telephone calls in between visits, then weekly, and when stable once a month. There will be a final visit at 6 months. The intervention includes routine collection of urine drug screens.

BEHAVIORAL

Augmented Usual Care

If not already waivered, PCPs will be trained and waivered to treat OUD with medications. All practices will have mental health clinicians to treat mild psychiatric disorders. 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.

BEHAVIORAL

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

This intervention includes the Collaborative Care Intervention plus Certified Recovery Specialist to assist with treatment engagement and retention.

Trial Locations (1)

19104

Penn Center for Primary Care, Philadelphia

All Listed Sponsors
collaborator

Weill Medical College of Cornell University

OTHER

lead

University of Pennsylvania

OTHER