Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD

NCT ID: NCT05817825

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2024-12-31

Brief Summary

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This study aims to test a remotely delivered IOP program ("SmartIOP") for OUD patients who are hospitalized for serious injection-related infections. This will be a pilot trial to assess the feasibility of the IOP program and examine OUD-related outcomes following discharge from the hospital.

Detailed Description

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The aim is to conduct a single-arm pilot study of 20 participants who are hospitalized for serious injection-related infections to complete the newly tailored program. The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) a peer recovery coach who will provide support and accountability to the participant. The feasibility of the intervention will be established by evaluating recruitment and the acceptability of the program according to a priori benchmarks. The study team will assess the program's preliminary efficacy by evaluating OUD-related outcomes for up to 28 days after discharge from the hospital. The study will be conducted at Brigham and Women's Hospital (BWH), an urban, 793-bed academic medical center located in Boston, MA, and a major teaching hospital for Harvard Medical School.

Conditions

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Opioid Use Disorder Serious Bacterial Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The trial is an open-label, single-arm, pilot feasibility trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) a peer recovery coach to provide support and accountability to the participant.

Group Type EXPERIMENTAL

Smart IOP Intervention

Intervention Type BEHAVIORAL

Smart IOP is a remotely delivered IOP program in operation since 2016, allowing patients to complete addiction treatment entirely online. The original program, consisting of 72 video modules across 8 different topics, will be adapted and tailored to hospitalized patients with serious infections from injection drug use. Participants will watch video content asynchronously, and will be required to correctly answer knowledge questions to proceed to the next module. The whole treatment program will require approximately 4 weeks to complete. Participants are also asked to answer questions about how to apply the knowledge to their own personal circumstances. The answers to these are reviewed by the peer recovery coach during weekly encounters. Videos can be viewed at a time that is most convenient to the participants. T

Peer Recovery Coach

Intervention Type BEHAVIORAL

Peer recovery coach, an individual in sustained recovery (\>5 years) and certified to be a coach, will meet weekly with the participant to review progress, answer questions about the videos, review answers to questions, and encourage continuation of treatment after discharge. These meetings will occur in-person or remotely.

Interventions

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Smart IOP Intervention

Smart IOP is a remotely delivered IOP program in operation since 2016, allowing patients to complete addiction treatment entirely online. The original program, consisting of 72 video modules across 8 different topics, will be adapted and tailored to hospitalized patients with serious infections from injection drug use. Participants will watch video content asynchronously, and will be required to correctly answer knowledge questions to proceed to the next module. The whole treatment program will require approximately 4 weeks to complete. Participants are also asked to answer questions about how to apply the knowledge to their own personal circumstances. The answers to these are reviewed by the peer recovery coach during weekly encounters. Videos can be viewed at a time that is most convenient to the participants. T

Intervention Type BEHAVIORAL

Peer Recovery Coach

Peer recovery coach, an individual in sustained recovery (\>5 years) and certified to be a coach, will meet weekly with the participant to review progress, answer questions about the videos, review answers to questions, and encourage continuation of treatment after discharge. These meetings will occur in-person or remotely.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* English-speaking adults aged 18 and above
* Any DSM-5 substance use disorder
* Can identify at least 2 individuals who can act as points of contact following discharge from the hospital

Exclusion Criteria

* Psychotic disorder, active suicidality, or homicidally
* Condition likely to be terminal during the study period
* Unable to perform consent due to impaired mental status
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Mclean Hospital

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joji Suzuki, MD

Director, Division of Addiction Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joji Suzuki, MD

Role: CONTACT

617-732-5752

Facility Contacts

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Joji Suzuki, MD

Role: primary

617-732-5752

Other Identifiers

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R21DA056799

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023P000709

Identifier Type: -

Identifier Source: org_study_id

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