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

Opioid-use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04817267
• Other study ID #: IRB00282938
• Status: Terminated
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Device:
• reSET-O app
The reSET-O app, a prescription digital therapeutic, provides cognitive behavioral therapy for opioid use disorder. The app provides psychoeducation related to opioid use, coping skills, and skills to avoid relapse.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayivew Emergency Department	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Pear Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of approached patients who are eligible for and interested in participation	Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.	3 months
Primary	Acceptability as assessed by the Treatment Acceptability Questionnaire	Participant responses to the Treatment Acceptability Questionnaire.	3 months
Primary	Acceptability as assessed by the System Usability Scale	Participant responses to the System Usability Scale.	3 months
Secondary	Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge	Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge will be used to assess Treatment Engagement.	30 days
Secondary	Percentage of drug-negative urine samples during the 3-month intervention	Percentage of drug-negative urine samples during the 3-month intervention will be used to assess Illicit opioid/other drug use.	3 months