Study 40 – Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (EXHIT ENTREY)

CTN-0098: Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (EXHIT ENTREY)

Investigator:  Gavin Bart, M.D., Ph.D.

Release Date:  TBA

Objective: The primary objective of this study is to define and refine best practices for hospital-initiated treatment of opioid use disorder (OUD) and post-discharge treatment engagement by NIDA/CTNs expertise in hospital-based addiction care. Engagement in OUD care on the 34th day following hospital discharge will be compared among participants randomized to extended-release buprenorphine (XR-BUP) versus those randomized to treatment as usual (TAU). Secondary objectives will compare safety, engagement in OUD care at 90- and 180-days post discharge, drug use, hospital readmissions, and emergency room visits among participants randomized to XR-BUP versus TAU.

Significance/Impact: OUDs impart significant morbidity and mortality. Hospitalizations associated with opioids continue to increase and are often complicated by infections and other significant comorbidities. Hospitalization may be an important locus of intervention for those with OUD. A multi-site study focused on hospitalized patients with OUD is needed to guide treatment of this large, high-risk, and expensive population. This study is a multi-site open-label randomized comparative effectiveness trial of XR-BUP versus TAU for hospitalized patients with a moderate or severe OUD seen by an addiction consultation service (ACS) and agreeing to initiate a medication for OUD (MOUD). We hypothesize that, compared to ACS TAU, a greater proportion of those randomized to ACS XR-BUP will be engaged in MOUD on the 34th day following hospital discharge.

Study Design/Methodology: Approximately 4-5 sites (hospitals) with existing ACSs experienced in hospital-initiated MOUD will be selected. Identification of patients with OUD will occur as per each site’s local practice. Approximately 314 hospitalized patients with OUD who were not receiving prescribed MOUD for at least 14 days prior to hospitalization and are willing to start MOUD including buprenorphine will be randomized 1:1 to two different strategies. After baseline assessments are performed, eligible participants will be randomized in a 1:1 ratio to XR-BUP or TAU. The randomization process will be performed by computer by the DSC. A permuted block
randomization procedure with random block sizes will be implemented to balance per site. The DSC statistician will review randomization data on a regular basis to ensure that the scheme is being implemented according to plan.

Prior to randomization, participants must provide consent for study participation and meet study eligibility criteria, including a diagnosis of moderate or severe OUD. The intervention will consist of initiation of XR-BUP compared to TAU (e.g., SL-BUP or methadone) prior to hospital discharge followed by local practice of linking patients to ongoing post-hospital MOUD care. The intervention does not specify what the ongoing MOUD care will consist of and research contact to evaluate primary and secondary outcomes will occur approximately 34, 90, and 180 days following hospital discharge. The primary outcome is engagement in OUD care on the 34th day following hospital discharge.

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