Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder

• Registration Number: NCT06827288
• Lead Sponsor: RAND

Brief Summary

The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable opioid use disorder (OUD).

Detailed Description

The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable OUD. The trial includes (1) two first stage components: the CA Bridge Model with Substance Use Navigator assisted treatment initiation and linkage to care (SUN) or CA Bridge plus immediate telehealth connection to an outpatient provider (SUN+TeleBridge); (2) a dynamic tailoring variable describing (non) response to the first stage: whether the patient has not filled an outpatient buprenorphine prescription at 30 days or whether the patient returns to the ED with an OUD-related event or self-reports non-adherence to buprenorphine within the first 90 days; (3) two second-stage components for non-responders; either ongoing buprenorphine treatment by an ED-based interim treatment team (ED-ITT) or ED-ITT augmented with behavioral health support (ED-ITT+BHS). First-stage responders will receive no further active intervention unless the participant returns to the ED or notifies the SUN about no longer taking buprenorphine within 90 days of study enrollment.

Hypothesis 1: The investigators hypothesize that the most intensive Adaptive Treatment Strategy (ATS) will lead to (a) more days of buprenorphine use and (b) a longer time to overdose, self-harm, or death compared to the least intensive ATS.

Hypothesis 2: The investigators hypothesize that (a) SUN+TeleBridge in the first stage of the ATS and (b) ED-ITT+BHS in the second stage of the ATS will each lead to more days of buprenorphine use and a longer time to overdose, self-harm, or death within the first 12 months compared to SUN and ED-ITT, respectively, and (c) there is a synergistic positive effect of receiving both SUN+TeleBridge and ED-ITT+BHS on days of buprenorphine use.

Hypothesis 3: The investigators hypothesize that the effect of SUN+TeleBridge versus SUN and the effect of ED-ITT+BHS versus ED-ITT among first stage non-responders will be larger among those with (a) a history of overdose at baseline and (b) co-occurring depression or PTSD at baseline relative to those who do not have either or those conditions.

Study Timeline

• Study Start: 2024-10-04
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24
• Primary Completion: 2027-11-01
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Presented for ED care at ARMC
• Age 18 or older
• Probable OUD diagnosis
• Speak and understand English or Spanish
• Have capacity to give informed consent
• Provide a signed and dated informed consent form

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
The number of days a buprenorphine prescription was filled in the 6 months after enrollment	6 months from date of enrollment

Secondary Outcome Measures

Name	Time	Method
The time to a composite measure of overdose, suicide, self-harm and death	6 months from date of enrollment

Trial Locations

Locations (1)

Arrowhead Regional Medical Center; 🇺🇸 Colton, California, United States