Opioid Use DisorderNCT05817825
Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD
A study testing Smart IOP Intervention and Peer Recovery Coach in people with Opioid Use Disorder and Serious Bacterial Infections, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Serious Bacterial Infections
- What is being tested?
- Smart IOP Intervention and Peer Recovery Coach
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychotic disorder, active suicidality, or homicidally
- Condition likely to be terminal during the study period
- Unable to perform consent due to impaired mental status
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Joji Suzuki, MD, 617-732-5752, jsuzuki2@bwh.harvard.edu
Joji Suzuki, MD
About this study
Official title: Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With Opioid Use Disorder Hospitalized With Serious Injection-related Infection
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.
Read the detailed description
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
- Opioid Use Disorder, Serious Bacterial Infections
- Being tested
- Smart IOP Intervention, Peer Recovery Coach
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart IOP InterventionBehavioural
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 CoachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Smart IOP Intervention; Behavioral: Peer Recovery Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately Post Intervention
Secondary outcomes (2)
Illicit opioid use
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.
Measured: 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up
Retention with MOUD treatment
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.
Measured: 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start17 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The trial is an open-label, single-arm, pilot feasibility trial.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Mclean Hospital
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817825
- Sponsor's protocol ID
- 2023P000709
- Other IDs
- R21DA056799
- Status last verified
- Jul 2024
- First submitted
- 7 Mar 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Szpak V, Velez A, Prostko S, Rosenblum N, Maurer R, Aguiar LJ, Weiss RD, Suzuki J. Pilot testing a novel remotely delivered intensive outpatient program for hospitalized patients with opioid use disorder. Addict Sci Clin Pract. 2025 Aug 1;20(1):61. doi: 10.1186/s13722-025-00589-4.
PubMed 40751223
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With Opioid Use Disorder Hospitalized With Serious Injection-related Infection
- ClinicalTrials.gov ID
- NCT05817825
- Acronym / sponsor ID
- 2023P000709
- Conditions
- Opioid Use Disorder, Serious Bacterial Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Mclean Hospital
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The trial is an open-label, single-arm, pilot feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Smart IOP Intervention, Behavioral: Peer Recovery CoachThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Psychotic disorder, active suicidality, or homicidally
- Condition likely to be terminal during the study period
- Unable to perform consent due to impaired mental status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart IOP InterventionSmart 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 | Behavioural | Treatment Group |
| Peer Recovery CoachPeer 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. | Behavioural | Treatment Group |
Primary outcome
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.
2 secondary outcomes
Illicit opioid use
Time frame: 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up
Retention with MOUD treatment
Time frame: 7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 40751223Szpak V, Velez A, Prostko S, Rosenblum N, Maurer R, Aguiar LJ, Weiss RD, Suzuki J. Pilot testing a novel remotely delivered intensive outpatient program for hospitalized patients with opioid use disorder. Addict Sci Clin Pract. 2025 Aug 1;20(1):61. doi: 10.1186/s13722-025-00589-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart IOP Intervention and Peer Recovery Coach in people with Opioid Use Disorder and Serious Bacterial Infections, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joji Suzuki, MD (617-732-5752, jsuzuki2@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention program (time frame: Immediately Post Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05817825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.