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

Completed · Not applicable

Conditions studied: Opioid-use Disorder, Mental Health Conditions

In brief

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.

Key facts

Study ID

NCT04245423

Run by

University of Pennsylvania

People needed

567

Starts

2020-12-15

Expected to finish

2026-03-28

Last updated by the study team

2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years and older;
• a diagnosis of opioid use disorder using DSM-5 criteria within the last 12 months OR have taken medication for opioid use disorder (MOUD) within the last 12 months;
• 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);
• meet criteria for depression, anxiety (panic disorder, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder), or PTSD;
• able to communicate in English; and
• willing to give informed consent.

You may not qualify if…

• 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); and
• lack of a phone.

Where it is running

• Penn Center for Primary Care — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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