Opioid-use DisorderNCT04129580
reSET-O RCT (Randomized Controlled Trial)
A study testing reSET-O app in people with Opioid-use Disorder, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This randomized controlled trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 19 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
- Recently starting outpatient treatment for OUD within the Penn State Health Hub and Spoke System of Care
- Initiating MAT with buprenorphine-naloxone (suboxone), buprenorphine (Subutex), or methadone. Since buprenorphine (Subutex) is an FDA approved MAT for pregnant women with OUD, pregnant women are eligible to participate in the research study, assuming they meet all other eligibility requirements.
- Prison inmates are eligible to participate in the study
- Ability to read, write, and comprehend English
Who cannot join
- Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT).
- Planning an outpatient detoxification
- Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)
- Less than 18 years of age
- Unable to read, write, and comprehend English
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania Psychiatric Institute
Harrisburg, Pennsylvania, 17110
About this study
Official title: A Randomized Clinical Trial of Comprehensive Cognitive Behavioral Therapy (CBT) Via reSET-O for a Hub and Spoke Medication Assisted Treatment (MAT) System of Care.
This randomized controlled trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment.
Read the detailed description
This randomized controlled trial research study will enroll 200 subjects, where half will be randomly assigned to treatment as usual (TAU) and the app, reSET-O (n = 100), and half will be assigned to TAU only (n = 100), in order to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. All subjects will participate in the study for a total of six months, and all subjects will attend five research appointments across the six months. Participants assigned to TAU + reSET-O will be expected to engage with the app, reSET-O, for the full six months. The app works as an extension of cognitive behavioral therapy as it provides psychoeducation related to opioid dependence and use, and is designed as an adjunctive treatment with medication assisted treatment for opioid use disorder.
- 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, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse,
| Study group | Role | What they receive |
|---|---|---|
| Treatment-As-Usual (TAU) + reSET-O | Experimental | Participants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O. Receives: Device: reSET-O app |
| TAU only | No intervention | Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in Treatment on MAT for 6 Months After Enrolling in the Study
reSET-O is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). The first outcome being measure is treatment retention. We want to examine if participants enrolled in the study will maintain on MAT for 6 months after enrollment. This will be evaluated based on the number of appointments attended by the research participants. Data mining through our systems electronic medical record (EMR) will be conducted in order to count the number of attended appointments for study participants to gauge their treatment retention.
Measured: 6 months
Secondary outcomes (5)
Opioid and Other Substance Abuse as Assessed Through Biological Specimen
Part of this study is looking at the effect of reSET-O on substance use. This will be measured by collecting urine drug screens to assess drug use (if any) at each research appointment. The number of endorsed drugs used (as indicated by a positive urine drug screen) will be counted and recorded for each research visit.
Measured: 6 months
Opioid and Other Substance Abuse as Assessed Through Participant Self-report
Part of this study is looking at the effect of reSET-o on substance use. This will be measured by participant self-report on the Timeline Follow Back Questionnaire (TLFB). The TLFB is a self-report measure that gages the participant's memory by using a calendar to assess drug use within a specific period of time. The number of endorsed drugs used (as indicated by the participant) will be counted and recorded for each research visit.
Measured: 6 months
Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10
Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as overall mental health symptoms as measured by participant self-report on the Kessler 10 (K-10). A score of one indicates that an individual experiences symptoms or issues "None of the time," whereas a score of five indicates that an individual experiences symptoms or issues "All of time." The scores are summed and total amounts will fall in one of four categories: Score under 20 = likely to be well; Score 20-24 = likely to have a mild mental disorder; Score 25-29 = likely to have a moderate mental disorder; and Score 30 or more = likely to have a severe mental disorder. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study.
Measured: 6 months
Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9
Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as mental health specific to depression as measured by the participant self-report on the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire that assesses depressive symptoms or issues using a likert scale from "0 to 3;" 0 indicating no symptoms or issues and 3 indicating symptoms or issues occurring nearly every day. Scores are summed to calculate a total score. Scores 1-4 indicated minimal depression; scores 5-9 indicate mild depression; scores 10-14 indicate moderate depression; scores 15-19 indicated moderately severe depression; and scores 20-27 indicate severe depression. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study.
Measured: 6 months
Mental Health Symptoms Related to PTSD as Assessed by the PCL-C
Part of this study is looking at the effect of reSET-O on 6 month adherence and mediation of improvements in quality of life outcomes such as mental health specific to post-traumatic stress disorder as measured by the participant self-report on the abbreviated PTSD Checklist-Civilian Version (PCL-C). The PCL-C is a 17 item questionnaire that assesses PTSD symptoms on a likert scale from one to five (one = no symptoms or issues; five = extreme symptoms or issues). The scores are summed and a score of 30 or more indicates clinical PTSD symptoms. Baseline measurements were assessed and compared with results at 24 weeks in each arm. A negative number indicates improvement over the course of the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start15 Sep 2020
- Primary completion14 Jul 2023
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Single group
- Model description
- Single site, randomized controlled trial research study.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Pear Therapeutics, Inc., National Institutes of Health (NIH), Research Foundation for Mental Hygiene, Inc.
- Responsible party
- Principal investigator, Sarah Kawasaki, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129580
- Sponsor's protocol ID
- 00012685
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2019
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Penn State's opioid use disorder clinic (opioid treatment program; OTP), housed at the Pennsylvania Psychiatric Institute will be housing and collecting all data. App data transfers will come from Pear Therapeutics, Inc. to the Penn State study team. This data will not include identifiable information. This data will include the number of modules completed per participant, as well as survey data (as assessed by the app) related to cravings and use. Data will be shared using a Penn State IT approved interface such as Kite Drive, Accelion, or File Drop. Penn State will in turn share data with Columbia University research team (collaborators on the study), for data analyses. Again, this data will be deidentified and will be shared via a Penn State IT approved system as mentioned above.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Comprehensive Cognitive Behavioral Therapy (CBT) Via reSET-O for a Hub and Spoke Medication Assisted Treatment (MAT) System of Care.
- ClinicalTrials.gov ID
- NCT04129580
- Acronym / sponsor ID
- 00012685
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Columbia University, Pear Therapeutics, Inc., National Institutes of Health (NIH), Research Foundation for Mental Hygiene, Inc.
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Posted 23 May 2024
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 trial research study will be evaluating an app, reSET-O, owned by Pear Therapeutics, Inc., to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment.
Detailed description
This randomized controlled trial research study will enroll 200 subjects, where half will be randomly assigned to treatment as usual (TAU) and the app, reSET-O (n = 100), and half will be assigned to TAU only (n = 100), in order to evaluate treatment retention rates in individuals with opioid use disorder after initiating medication assisted treatment. All subjects will participate in the study for a total of six months, and all subjects will attend five research appointments across the six months. Participants assigned to TAU + reSET-O will be expected to engage with the app, reSET-O, for the full six months. The app works as an extension of cognitive behavioral therapy as it provides psychoeducation related to opioid dependence and use, and is designed as an adjunctive treatment with medication assisted treatment for opioid use disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single site, randomized controlled trial research study.
| Arm | Type | Receives |
|---|---|---|
| Treatment-As-Usual (TAU) + reSET-O | Experimental | Device: reSET-O appParticipants randomly assigned to this arm will receive their TAU alongside the use of the app, reSET-O. |
| TAU only | No intervention | –Participants randomly assigned to this arm will receive their TAU only (no use of the app, reSET-O). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
- Recently starting outpatient treatment for OUD within the Penn State Health Hub and Spoke System of Care
- Initiating MAT with buprenorphine-naloxone (suboxone), buprenorphine (Subutex), or methadone. Since buprenorphine (Subutex) is an FDA approved MAT for pregnant women with OUD, pregnant women are eligible to participate in the research study, assuming they meet all other eligibility requirements.
- Prison inmates are eligible to participate in the study
Key exclusion criteria (5 listed)
- Initiating maintenance treatment that does not include MAT or switching to a maintenance treatment that does not include MAT (i.e.: detoxification and counseling treatment only without MAT).
- Planning an outpatient detoxification
- Judged by the evaluating physician or allied clinician to need a higher level of care (i.e.: residential or inpatient treatment)
- Less than 18 years of age
- Unable to read, write, and comprehend English
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, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse, | Device | Treatment-As-Usual (TAU) + reSET-O |
Primary outcome
Retention in Treatment on MAT for 6 Months After Enrolling in the Study
Time frame: 6 months
reSET-O is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). The first outcome being measure is treatment retention. We want to examine if participants enrolled in the study will maintain on MAT for 6 months after enrollment. This will be evaluated based on the number of appointments attended by the research participants. Data mining through our systems electronic medical record (EMR) will be conducted in order to count the number of attended appointments for study participants to gauge their treatment retention.
5 secondary outcomes
Opioid and Other Substance Abuse as Assessed Through Biological Specimen
Time frame: 6 months
Opioid and Other Substance Abuse as Assessed Through Participant Self-report
Time frame: 6 months
Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10
Time frame: 6 months
Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9
Time frame: 6 months
Mental Health Symptoms Related to PTSD as Assessed by the PCL-C
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Penn State's opioid use disorder clinic (opioid treatment program; OTP), housed at the Pennsylvania Psychiatric Institute will be housing and collecting all data. App data transfers will come from Pear Therapeutics, Inc. to the Penn State study team. This data will not include identifiable information. This data will include the number of modules completed per participant, as well as survey data (as assessed by the app) related to cravings and use. Data will be shared using a Penn State IT approved interface such as Kite Drive, Accelion, or File Drop. Penn State will in turn share data with Columbia University research team (collaborators on the study), for data analyses. Again, this data will be deidentified and will be shared via a Penn State IT approved system as mentioned above.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Milton S. Hershey Medical Center 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 6 inclusion and 5 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 20 Nov 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?
Yes. Results are posted in the registry (first posted 23 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention in Treatment on MAT for 6 Months After Enrolling in the Study (time frame: 6 months). 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 20 Nov 2024.