Clinical trial NCT04218201: Subthreshold Opioid Use Disorder Prevention (STOP) Trial
Official title: Subthreshold Opioid Use Disorder Prevention (STOP) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-01-06
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Subthreshold Opioid Use Disorder Prevention (STOP) trial will test the efficacy of a primary care intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adults with unhealthy use of illicit or prescribed opioids. STOP is a collaborative care model. A cluster-randomized trial, conducted in 5 primary care sites, with 100 PCPs and 300adult primary care patients, will test the efficacy of STOP versus enhanced usual care (EUC). The STOP intervention, if proven efficacious, will provide a solution to preventing OUD among patients who are most at risk, thus addressing a key aspect of the current opioid crisis.

Detailed description: This cluster randomized trial, conducted in primary care clinics and randomized at the level of the PCP, will compare the STOP intervention to enhanced usual care (EUC) for 12 months. Patients who are eligible and enroll will receive the intervention according to the assignment of their PCP. In the EUC arm, PCPs conduct primary care as usual, without support of the nurse care manager. Patient participants receive an educational pamphlet about overdose prevention and watch a brief video on "healthy living" that is not specific to substance use. In the STOP arm, PCPs and their enrolled patient participants receive the STOP intervention, consisting of a NCM, brief advice about health risks of opioid misuse, and telephone health coaching. Patient participants in either arm who are found by clinical providers to have developed a moderate-severe OUD at any time during the study can be offered medication for OUD and linked to treatment by clinical staff in the EUC arm, and the NCM in the STOP arm, to formal assessment and MOUD treatment.

Eligibility criteria: PCP Inclusion Criteria

* Licensed medical professional (MD, DO, PA, NP).
* Currently providing care to approximately 4 or more adult patients (18 years or older) who are receiving chronic opioid treatment and/or have risky opioid use.
* Total patient volume is approximately 40 or more adult patients (18 years or older) per week on a typical week
* Willing to be randomized to either of the two study conditions

Patient Participant Inclusion Criteria

* PCP is enrolled in the study.
* Age 18 years or older at time of prescreening.
* Proficient in spoken and written English, as determined by patient self-report and research staff evaluation.
* Risky opioid use in the past 90 days from date of prescreening, as determined by a TAPS score \>1 for heroin and/or prescription opioids and/or a positive response (\>Never) to any of the three COMM items indicating taking more opioid medication than prescribed
* Access to phone that can receive text messages, and access to internet (via smartphone, tablet, or computer), per patient self-report.
* Able to provide informed consent.

PCP Exclusion Criteria:

* Planning to resign from the clinic in the next 24 months, per PCP self-report.
* Planning to change their schedule in the next 24 months such that they would no longer meet the inclusion criteria for patient volume, per PCP self-report.

Patient Participant Exclusion Criteria:

* Patients with moderate-severe OUD, defined as meeting 4 or more DSM-5 criteria for OUD at screening, as assessed by research staff using the modified-CIDI opioid items.
* Receiving MOUD or engaged in an opioid treatment program in the past 30 days from screening date, per patient self-report.
* Receiving opioids for end of life care, per patient self-report.
* Pregnancy (females age 18-50), as determined by patient self-report at the time of screening.
* Are currently in jail, prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
* Plan to leave the area or the clinical practice within the next 12 months, per patient self-report.
* Other factors that may cause harm or increased risk to the participant or close contacts or preclude the patient's full adherence with or completion of the study.

Primary outcomes:
measure: Days of Risky Opioid Use in Past 180 Days
timeFrame: Up to Month 6
Secondary outcomes:
measure: Days of Risky Opioid Use in Past 180 Days
timeFrame: Month 7 up to Month 12
measure: Days of Benzodiazepine Use in Past 180 Days
timeFrame: Up to Month 6
measure: Days of Benzodiazepine Use in Past 180 Days
timeFrame: Month 7 up to Month 12
measure: Days of Stimulant Use in Past 180 Days
timeFrame: Up to Month 6
measure: Days of Stimulant Use in Past 180 Days
timeFrame: Month 7 up to Month 12
measure: Days of Marijuana Use in Past 180 Days
timeFrame: Up to Month 6
measure: Days of Marijuana Use in Past 180 Days
timeFrame: Month 7 up to Month 12
measure: Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.
timeFrame: Up to Month 6
measure: Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.
timeFrame: Month 7 up to Month 12
measure: Days of Binge Alcohol Use in Past 180 Days
timeFrame: Up to Month 6
measure: Days of Binge Alcohol Use in Past 180 Days
timeFrame: Month 7 up to Month 12
measure: Number of Participants With Opioid Use Disorder
timeFrame: Month 6
measure: Number of Participants With Opioid Use Disorder
timeFrame: Month 12
measure: Number of Participants With Drug (Other Than Opioid) Use Disorder
timeFrame: Month 6
measure: Number of Participants With Drug (Other Than Opioid) Use Disorder
timeFrame: Month 12
measure: Number of Participants With Alcohol Use Disorder
timeFrame: Month 6
measure: Number of Participants With Alcohol Use Disorder
timeFrame: Month 12
measure: Change in Overdose Risk Behavior Questionnaire Score
timeFrame: Baseline, Month 6
measure: Change in Overdose Risk Behavior Questionnaire Score
timeFrame: Baseline, Month 12
measure: Episodes of Non-Fatal Overdose
timeFrame: Month 6
measure: Episodes of Non-Fatal Overdose
timeFrame: Month 12
measure: Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity
timeFrame: Month 6
measure: Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity
timeFrame: Month 12
measure: Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference
timeFrame: Month 6
measure: Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference
timeFrame: Month 12
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score
timeFrame: Month 6
measure: PROMIS Anxiety Short Form Score
timeFrame: Month 12
measure: Patient Health Questionnaire-8 (PHQ-8) Score
timeFrame: Month 6
measure: Patient Health Questionnaire-8 (PHQ-8) Score
timeFrame: Month 12
measure: Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)
timeFrame: Month 6
measure: Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)
timeFrame: Month 12
measure: Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)
timeFrame: Month 6
measure: Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)
timeFrame: Month 12
measure: Number of Acute Care Events
timeFrame: Up to Month 6
measure: Number of Acute Care Events
timeFrame: Month 7 up to Month 12
measure: Number of Acute Care Events (Self-Report)
timeFrame: Up to Month 6
measure: Number of Acute Care Events (Self-Report)
timeFrame: Month 7 up to Month 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone
name: Jennifer McNeely, MD
role: PRINCIPAL_INVESTIGATOR
References: