Opioid Use DisorderNCT05412966
Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence
A study testing PEAR-002B and reSET-O in people with Opioid Use Disorder, run by Pear Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- PEAR-002B and reSET-O
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 16 Dec 2022
- 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
- Provide written informed consent prior to any study specific assessments being performed
- Male or female ≥18 years of age, inclusive
- English proficiency to meaningfully participate in consent process, assessment and intervention
- Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use)
- Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment
- Capable of using common software applications on an internet-enabled mobile device (smart phone or tablet)
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- Interested in testing or using PEAR-002b
- No prior history of reSET-O use
- Has not participated in any other investigational drug trials within the past 30 days (or within 5 half-lives of study drug, whichever is longer) of enrollment
- Is considered appropriate for participation by their clinician
Who cannot join
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy
- DSM-5 diagnosis of OUD and already on buprenorphine
- Planning to move out of the geographic area within 2 months
- Unable to use English to participate in the consent process, the interventions, or assessments
- Inability to comply with study procedures, due to severe medical conditions or otherwise
- Currently receiving inpatient treatment for OUD
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Hassman Research Institute, LLC
Berlin, New Jersey, 08009
About this study
Official title: A Feasibility Study of PEAR-002b, a Novel Prescription Digital Therapeutic to Support Unobserved Buprenorphine Initiation and Adherence in Opioid Use Disorder Outpatients
The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.
Read the detailed description
The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O.
This feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process.
This study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.
- Conditions
- Opioid Use Disorder
- Being tested
- PEAR-002B, reSET-O
- Keywords
- digital therapeutic
- 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.
PEAR-002BDevice
PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder
reSET-ODevice
reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
| Study group | Role | What they receive |
|---|---|---|
| PEAR-002B / reSET-O | Experimental | Digital Therapeutic Receives: Device: PEAR-002B; Device: reSET-O |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEAR-002B User Satisfaction Surveys
Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints
Measured: Week 1
PEAR-002B Qualitative User Experience Interviews
Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
Measured: Week 1
Buprenorphine Initiation Success
Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit
Measured: Week 1
Medication Adherence Rates
Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine
Measured: From Week 1 to Week 4
Secondary outcomes (3)
PEAR-002B Engagement Data
PEAR-002B engagement rates as measured by participant use patterns data
Measured: From Baseline to Week 1
reSET-O Qualitative User Experience Interviews
Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
Measured: Week 4
reSET-O User Satisfaction Surveys
Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start4 Nov 2022
- Primary completion23 Nov 2022
- Study completion16 Dec 2022
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.
- 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
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pear Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Foundation Research Institute, Whitman-Walker Institute, Inc., National Institute on Drug Abuse (NIDA), Hassman Research Institute, LLC
- Responsible party
- Sponsor
- Investigators
- Michael Hassman, Study director, Hassman Research Institute, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412966
- Sponsor's protocol ID
- PEAR-002-101
- Other IDs
- R44DA049493
- Status last verified
- Jan 2023
- First submitted
- 19 May 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Luderer H, Enman N, Gerwien R, Braun S, McStocker S, Xiong X, Koebele C, Cannon C, Glass J, Maricich Y. A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. JMIR Res Protoc. 2023 Jan 20;12:e43122. doi: 10.2196/43122.
PubMed 36662568
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of PEAR-002b, a Novel Prescription Digital Therapeutic to Support Unobserved Buprenorphine Initiation and Adherence in Opioid Use Disorder Outpatients
- ClinicalTrials.gov ID
- NCT05412966
- Acronym / sponsor ID
- PEAR-002-101
- Conditions
- Opioid Use Disorder
- Keywords
- digital therapeutic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pear Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Foundation Research Institute, Whitman-Walker Institute, Inc., National Institute on Drug Abuse (NIDA), Hassman Research Institute, LLC
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 9 Jun 2022 (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.
The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.
Detailed description
The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O.
This feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process.
This study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEAR-002B / reSET-O | Experimental | Device: PEAR-002B, Device: reSET-ODigital Therapeutic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide written informed consent prior to any study specific assessments being performed
- Male or female ≥18 years of age, inclusive
- English proficiency to meaningfully participate in consent process, assessment and intervention
- Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use)
- Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment
Key exclusion criteria (7 listed)
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy
- DSM-5 diagnosis of OUD and already on buprenorphine
- Planning to move out of the geographic area within 2 months
- Unable to use English to participate in the consent process, the interventions, or assessments
- Inability to comply with study procedures, due to severe medical conditions or otherwise
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 |
|---|---|---|
| PEAR-002BPEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder | Device | PEAR-002B / reSET-O |
| reSET-OreSET-O is an FDA-authorized mobile application treatment for opioid use disorder. | Device | PEAR-002B / reSET-O |
Primary outcome
PEAR-002B User Satisfaction Surveys
Time frame: Week 1
Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints
PEAR-002B Qualitative User Experience Interviews
Time frame: Week 1
Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes
Buprenorphine Initiation Success
Time frame: Week 1
Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit
Medication Adherence Rates
Time frame: From Week 1 to Week 4
Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine
3 secondary outcomes
PEAR-002B Engagement Data
Time frame: From Baseline to Week 1
reSET-O Qualitative User Experience Interviews
Time frame: Week 4
reSET-O User Satisfaction Surveys
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Derived from this study: PubMed 36662568Luderer H, Enman N, Gerwien R, Braun S, McStocker S, Xiong X, Koebele C, Cannon C, Glass J, Maricich Y. A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. JMIR Res Protoc. 2023 Jan 20;12:e43122. doi: 10.2196/43122.
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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.
Michael Hassman study director
Hassman Research Institute, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAR-002B and reSET-O in people with Opioid Use Disorder, run by Pear Therapeutics, Inc. 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 10 inclusion and 7 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: finished, as of the sponsor's last update on 9 Jan 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PEAR-002B User Satisfaction Surveys (time frame: Week 1). The study lists 4 primary outcomes in all. 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 NCT05412966, 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 9 Jan 2023.