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

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TitleCollaborative care in the treatment of opioid use disorder and mental health conditions in primary care: A clinical study protocol.
Publication TypeJournal Article
Year of Publication2021
AuthorsHarris, RArden, Mandell, DS, Kampman, KM, Bao, Y, Campbell, K, Cidav, Z, Coviello, DM, French, R, Livesey, C, Lowenstein, M, Lynch, KG, McKay, JR, Oslin, DW, Wolk, CBenjamin, Bogner, HR
JournalContemp Clin Trials
Volume103
Pagination106325
Date Published2021 04
ISSN1559-2030
KeywordsBuprenorphine, Humans, Mental Health, Opiate Substitution Treatment, Opioid-Related Disorders, Primary Health Care, Randomized Controlled Trials as Topic
Abstract

BACKGROUND: People with opioid use disorder (OUD) often have a co-occurring psychiatric disorder, which elevates the risk of morbidity and mortality. Promising evidence supports the use of collaborative care for treating people with OUD in primary care. Whether collaborative care interventions that treat both OUD and psychiatric disorders will result in better outcomes is presently unknown.

METHODS: The Whole Health Study is a 3-arm randomized controlled trial designed to test collaborative care treatment for OUD and the psychiatric disorders that commonly accompany OUD. Approximately 1200 primary care patients aged ≥18 years with OUD and depression, anxiety, or PTSD will be randomized to one of three conditions: (1) Augmented Usual Care, which consists of a primary care physician (PCP) waivered to prescribe buprenorphine and an addiction psychiatrist to consult on medication-assisted treatment; (2) Collaborative Care, which consists of a waivered PCP, a mental health care manager trained in psychosocial treatments for OUD and psychiatric disorders, and an addiction psychiatrist who provides consultation for OUD and mental health; or (3) Collaborative Care Plus, which consists of all the elements of the Collaborative Care arm plus a Certified Recovery Specialist to help with treatment engagement and retention. Primary outcomes are six-month rates of opioid use and six-month rates of remission of co-occurring psychiatric disorders.

DISCUSSION: The Whole Health Study will investigate whether collaborative care models that address OUD and co-occurring depression, anxiety, or PTSD will result in better patient outcomes. The results will inform clinical care delivery during the current opioid crisis.

CLINICAL TRIALS REGISTRATION: www.clinicaltrials.gov registration: NCT04245423.

DOI10.1016/j.cct.2021.106325
Alternate JournalContemp Clin Trials
PubMed ID33631356
PubMed Central IDPMC8117118
Grant ListT32 NR007104 / NR / NINR NIH HHS / United States
UF1 MH121944 / MH / NIMH NIH HHS / United States