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NCT Number: NCT05817825

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Serious Bacterial Infections Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Joji Suzuki, MD

CONTACT

[email protected]

617-732-5752

Joji Suzuki, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Feasibility of the intervention program

    Time frame: Immediately Post Intervention

    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.

Secondary outcomes

  1. Illicit opioid use

    Time frame: 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up

    As an exploratory outcome, we will evaluate, using the Timeline follow back (TLFB), the proportion of days using illicit opioids during the follow-up period compared to baseline.

  2. Retention with MOUD treatment

    Time frame: 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up

    As an exploratory outcome, we will evaluate the proportion of participants who successfully engaged with addiction treatment following completion of the intervention compared to baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Joji Suzuki, MD

CONTACT

[email protected]

617-732-5752

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Mclean Hospital
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With Opioid Use Disorder Hospitalized With Serious Injection-related Infection

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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