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N/A N=321 Randomized Single-blind Prevention

Subthreshold Opioid Use Disorder Prevention (STOP) Trial

Opioid-use Disorder

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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