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

Johns Hopkins University

Status: Terminated

Conditions: Opioid-use Disorder

Treatments: Device: reSET-O app

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04817267

IRB00282938

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

reSET-O + Treatment-As-Usual (TAU)

Experimental group

Description:

Participants randomly assigned to this group will receive the TAU plus the reSET-O app.

Treatment:

Device: reSET-O app

Treatment-As-Usual (TAU)

No Intervention group

Description:

Participants randomly assigned to this group will receive the TAU only (no use of the reSET-O app).