Opioid-use DisorderNCT04817267
Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
A study testing reSET-O app in people with Opioid-use Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- reSET-O app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 1 May 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- Opioid use disorder
- Eligible for buprenorphine treatment
- Has reSET-O compatible mobile device
Who cannot join
- Pregnancy
- Significant psychiatric comorbidity
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayivew Emergency Department
Baltimore, Maryland, 21224
About this study
This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.
Read the detailed description
This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.
- Conditions
- Opioid-use Disorder
- Being tested
- reSET-O app
- 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.
reSET-O appDevice
The reSET-O app, a prescription digital therapeutic, provides cognitive behavioral therapy for opioid use disorder. The app provides psychoeducation related to opioid use, coping skills, and skills to avoid relapse.
| Study group | Role | What they receive |
|---|---|---|
| reSET-O + Treatment-As-Usual (TAU) | Experimental | Participants randomly assigned to this group will receive the TAU plus the reSET-O app. Receives: Device: reSET-O app |
| Treatment-As-Usual (TAU) | No intervention | Participants randomly assigned to this group will receive the TAU only (no use of the reSET-O app). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of approached patients who are eligible for and interested in participation
Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.
Measured: 3 months
Acceptability as assessed by the Treatment Acceptability Questionnaire
Participant responses to the Treatment Acceptability Questionnaire.
Measured: 3 months
Acceptability as assessed by the System Usability Scale
Participant responses to the System Usability Scale.
Measured: 3 months
Secondary outcomes (2)
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge will be used to assess Treatment Engagement.
Measured: 30 days
Percentage of drug-negative urine samples during the 3-month intervention
Percentage of drug-negative urine samples during the 3-month intervention will be used to assess Illicit opioid/other drug use.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start11 Mar 2022
- Primary completion1 Jan 2023
- Study completion1 May 2024
Why it stopped: ReSET-O product no longer available, Pear Therapeutics, Inc. filed for bankruptsy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Pear Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- August Holtyn, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817267
- Sponsor's protocol ID
- IRB00282938
- Status last verified
- May 2024
- First submitted
- 23 Mar 2021
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
- ClinicalTrials.gov ID
- NCT04817267
- Acronym / sponsor ID
- IRB00282938
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: ReSET-O product no longer available, Pear Therapeutics, Inc. filed for bankruptsy
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Pear Therapeutics, Inc.
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 26 Mar 2021 (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 randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.
Detailed description
This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reSET-O + Treatment-As-Usual (TAU) | Experimental | Device: reSET-O appParticipants randomly assigned to this group will receive the TAU plus the reSET-O app. |
| Treatment-As-Usual (TAU) | No intervention | –Participants randomly assigned to this group will receive the TAU only (no use of the reSET-O app). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old
- Opioid use disorder
- Eligible for buprenorphine treatment
- Has reSET-O compatible mobile device
Key exclusion criteria (2 listed)
- Pregnancy
- Significant psychiatric comorbidity
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 |
|---|---|---|
| reSET-O appThe reSET-O app, a prescription digital therapeutic, provides cognitive behavioral therapy for opioid use disorder. The app provides psychoeducation related to opioid use, coping skills, and skills to avoid relapse. | Device | reSET-O + Treatment-As-Usual (TAU) |
Primary outcome
Percentage of approached patients who are eligible for and interested in participation
Time frame: 3 months
Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.
Acceptability as assessed by the Treatment Acceptability Questionnaire
Time frame: 3 months
Participant responses to the Treatment Acceptability Questionnaire.
Acceptability as assessed by the System Usability Scale
Time frame: 3 months
Participant responses to the System Usability Scale.
2 secondary outcomes
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge
Time frame: 30 days
Percentage of drug-negative urine samples during the 3-month intervention
Time frame: 3 months
Results and safety
The study was stopped early (reason given: ReSET-O product no longer available, Pear Therapeutics, Inc. filed for bankruptsy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: No
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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.
August Holtyn principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reSET-O app in people with Opioid-use Disorder, run by Johns Hopkins University 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 May 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?
The study was stopped early (reason given: ReSET-O product no longer available, Pear Therapeutics, Inc. filed for bankruptsy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of approached patients who are eligible for and interested in participation (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2024.