Clinical trial NCT04129580: reSET-O RCT (Randomized Controlled Trial)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Pear Therapeutics, Inc.
name: National Institutes of Health (NIH)
name: Research Foundation for Mental Hygiene, Inc.
First posted: 2019-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single site, randomized controlled trial research study.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Retention in Treatment on MAT for 6 Months After Enrolling in the Study
timeFrame: 6 months
Secondary outcomes:
measure: Opioid and Other Substance Abuse as Assessed Through Biological Specimen
timeFrame: 6 months
measure: Opioid and Other Substance Abuse as Assessed Through Participant Self-report
timeFrame: 6 months
measure: Overall Mental Health Symptoms Related to Depression and Anxiety as Assessed by the K-10
timeFrame: 6 months
measure: Mental Health Symptoms Specific to Depression as Assessed by the PHQ-9
timeFrame: 6 months
measure: Mental Health Symptoms Related to PTSD as Assessed by the PCL-C
timeFrame: 6 months
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Pennsylvania Psychiatric Institute
state: Pennsylvania
Study officials:
References: