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

NCT05817825 | Recruiting

• 2 other identifiers: 2023P000709R21DA056799
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder; Serious Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• Feasibility of the intervention program

  We expect the results to demonstrate adequate feasibility, as defined by exceeding the threshold for adequate recruitment feasibility and good program acceptability. Adequate recruitment feasibility is defined as enrolling more than 70% of those eligible individuals. Excellent program acceptability is defined as \>70% of the participants complete at least 70% of the Smart IOP intervention, and good program acceptability if \>60% of participants did.

  Immediately Post Intervention

Secondary Outcomes (2)

• Illicit opioid use

  7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up

• Retention with MOUD treatment

  7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up

Study Arms (1)

Treatment Group

EXPERIMENTAL

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.

Behavioral: Smart IOP Intervention; Behavioral: Peer Recovery Coach

Interventions

Smart IOP Intervention 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

Treatment Group

Peer Recovery Coach 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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Mclean Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Joji Suzuki, MD

CONTACT

617-732-5752; jsuzuki2@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Model Details: The trial is an open-label, single-arm, pilot feasibility trial.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 18, 2023
• Study Start: November 17, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

US (1)