NCT05817825 · Brigham and Women's Hospital
Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With OUD
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Collaborators
National Institute on Drug Abuse (NIDA), Mclean Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 3, 2024 · Source of record for eligibility and locations