N/A
N=321
Subthreshold Opioid Use Disorder Prevention (STOP) Trial
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04218201 ↗Enrolled (actual)
321
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Days of Risky Opioid Use in Past 180 Days — 12.2; 15.5 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PCP brief advice (Behavioral); Video doctor (Behavioral); Telephone health coaching (Behavioral); Nurse Care Manager (NCM) intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days of Risky Opioid Use in Past 180 Days |
10.7; 10.1 | — |
| SECONDARY Days of Risky Opioid Use in Past 180 Days |
10.7; 10.1 | — |
| SECONDARY Days of Benzodiazepine Use in Past 180 Days |
2.9; 3 | — |
| SECONDARY Days of Benzodiazepine Use in Past 180 Days |
2.9; 3 | — |
| SECONDARY Days of Stimulant Use in Past 180 Days |
2.0; 0.9 | — |
| SECONDARY Days of Stimulant Use in Past 180 Days |
2.0; 0.9 | — |
| SECONDARY Days of Marijuana Use in Past 180 Days |
33.2; 34.0 | — |
| SECONDARY Days of Marijuana Use in Past 180 Days |
33.2; 34.0 | — |
| SECONDARY Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days. |
0.0; 0.0 | — |
| SECONDARY Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days. |
0.0; 0.0 | — |
| SECONDARY Days of Binge Alcohol Use in Past 180 Days |
7.0; 11.2 | — |
| SECONDARY Days of Binge Alcohol Use in Past 180 Days |
7.0; 11.2 | — |
| SECONDARY Number of Participants With Opioid Use Disorder |
3; 6 | — |
| SECONDARY Number of Participants With Opioid Use Disorder |
3; 6 | — |
| SECONDARY Number of Participants With Drug (Other Than Opioid) Use Disorder |
8; 22 | — |
| SECONDARY Number of Participants With Drug (Other Than Opioid) Use Disorder |
8; 22 | — |
| SECONDARY Number of Participants With Alcohol Use Disorder |
9; 20 | — |
| SECONDARY Number of Participants With Alcohol Use Disorder |
9; 20 | — |
| SECONDARY Change in Overdose Risk Behavior Questionnaire Score |
-1.61; -1.15 | — |
| SECONDARY Change in Overdose Risk Behavior Questionnaire Score |
-1.61; -1.15 | — |
| SECONDARY Episodes of Non-Fatal Overdose |
0.3; 0.3 | — |
| SECONDARY Episodes of Non-Fatal Overdose |
0.3; 0.3 | — |
| SECONDARY Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity |
4.46; 3.98 | — |
| SECONDARY Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity |
4.46; 3.98 | — |
| SECONDARY Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference |
4.14; 3.87 | — |
| SECONDARY Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference |
4.14; 3.87 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score |
9.99; 9.66 | — |
| SECONDARY PROMIS Anxiety Short Form Score |
10.27; 9.63 | — |
| SECONDARY Patient Health Questionnaire-8 (PHQ-8) Score |
6.39; 5.68 | — |
| SECONDARY Patient Health Questionnaire-8 (PHQ-8) Score |
6.39; 5.68 | — |
| SECONDARY Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS) |
39.51; 41.84 | — |
| SECONDARY Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS) |
39.51; 41.84 | — |
| SECONDARY Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS) |
46.11; 46.05 | — |
| SECONDARY Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS) |
46.11; 46.05 | — |
| SECONDARY Number of Acute Care Events |
0.45; 0.30 | — |
| SECONDARY Number of Acute Care Events |
0.45; 0.30 | — |
| SECONDARY Number of Acute Care Events (Self-Report) |
0.28; 0.20 | — |
| SECONDARY Number of Acute Care Events (Self-Report) |
0.28; 0.20 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04218201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.