Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings

Not Applicable

Terminated

• Conditions: Opioid-use Disorder
• Interventions: Device: reSET-O app

• Registration Number: NCT04817267
• Lead Sponsor: Johns Hopkins University

Brief Summary

This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.

Detailed Description

This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-26
• Study Start: 2022-03-11
• Primary Completion: 2023-01-01
• Status Verified: 2024-05
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 18-65 years old
• Opioid use disorder
• Eligible for buprenorphine treatment
• Has reSET-O compatible mobile device

Exclusion Criteria

• Pregnancy
• Significant psychiatric comorbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
reSET-O + Treatment-As-Usual (TAU)	reSET-O app	Participants randomly assigned to this group will receive the TAU plus the reSET-O app.

Primary Outcome Measures

Name	Time	Method
Acceptability as assessed by the System Usability Scale	3 months	Participant responses to the System Usability Scale.
Percentage of approached patients who are eligible for and interested in participation	3 months	Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.
Acceptability as assessed by the Treatment Acceptability Questionnaire	3 months	Participant responses to the Treatment Acceptability Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Percentage of drug-negative urine samples during the 3-month intervention	3 months	Percentage of drug-negative urine samples during the 3-month intervention will be used to assess Illicit opioid/other drug use.
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge	30 days	Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge will be used to assess Treatment Engagement.

Trial Locations

Locations (1)

Johns Hopkins Bayivew Emergency Department; 🇺🇸 Baltimore, Maryland, United States