Subthreshold Opioid Use Disorder Prevention (STOP) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 321
- Locations
- 1
- Primary Endpoint
- Days of Risky Opioid Use in Past 180 Days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Days of Risky Opioid Use in Past 180 Days
Time Frame: Up to Month 6
Self-reported number of days of risky (illicit or nonmedical) opioid use in the past 180 days, assessed at 6 months after the baseline visit using single items from the Addiction Severity Index. Illicit opioid use includes use of heroin or synthetic opioids. Nonmedical opioid use includes using prescribed opioids more frequently or at higher doses than instructed on the prescription (e.g., taking 2 tablets when the prescription indicates a dose of 1 tablet), or taking pharmaceutical opioids that were not prescribed to them. Prescribed opioids may be prescribed by the participating PCP or by another medical provider. The measure is calculated as the sum of all days of use reported on the assessments of past 30-day drug use for the first 6 months (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).
Secondary Outcomes
- Days of Risky Opioid Use in Past 180 Days(Month 7 up to Month 12)
- Days of Benzodiazepine Use in Past 180 Days(Month 7 up to Month 12)
- Days of Stimulant Use in Past 180 Days(Month 7 up to Month 12)
- Days of Marijuana Use in Past 180 Days(Month 7 up to Month 12)
- Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.(Month 7 up to Month 12)
- Days of Binge Alcohol Use in Past 180 Days(Month 7 up to Month 12)
- Number of Participants With Opioid Use Disorder(Month 12)
- Number of Participants With Drug (Other Than Opioid) Use Disorder(Month 12)
- Number of Participants With Alcohol Use Disorder(Month 12)
- Change in Overdose Risk Behavior Questionnaire Score(Baseline, Month 12)
- Episodes of Non-Fatal Overdose(Month 12)
- Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity(Month 12)
- Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference(Month 12)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score(Month 6)
- PROMIS Anxiety Short Form Score(Month 12)
- Patient Health Questionnaire-8 (PHQ-8) Score(Month 12)
- Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)(Month 12)
- Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)(Month 12)
- Number of Acute Care Events(Month 7 up to Month 12)
- Number of Acute Care Events (Self-Report)(Month 7 up to Month 12)