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Completed

NCT Number: NCT04218201

Subthreshold Opioid Use Disorder Prevention (STOP) Trial

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCP brief advice

Behavioral

Brief advice will be delivered by the patient participant's PCP as part of the medical visit or via phone call. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the research staff. The summary advises the PCP that their patient participant screened positive for risky opioid use, lists the patient participant's screening results (TAPS Tool +/- COMM) and gives a suggested counseling script. The counseling script will include specific advice on opioid-related risks, will inform patient participants of resources to help them reduce their risk, and will include a recommendation to reduce their risk behavior.

Video doctor

Behavioral

During the baseline visit with the research staff, patient participants will view a video on tablet or desktop computer that reinforces the PCP's counseling. The video is a recording of a provider delivering brief advice about opioid use that includes the same elements covered in the summary report outlined above.

Telephone health coaching

Behavioral

All patient participants in the STOP arm will receive telephonic health coaching sessions at approximately 2- and 4-weeks post-baseline. Patient participants who may benefit from additional coaching (for example, those who do not improve or who experience clinical worsening of unhealthy opioid use) may receive additional coaching sessions (approximately 4 sessions) from the telephone health coach. Coaching is delivered from a centralized call center, by staff that receive standardized training and supervision. To the extent possible, calls will be scheduled at the patient participant's convenience (e.g., evenings, weekends).

Nurse Care Manager (NCM) intervention

Behavioral

NCMs will provide health education and counseling on risk reduction, overdose prevention and self-management skills. Patient participants will be asked to participate in a baseline visit with the NCM, which will occur on the same day as the baseline research visit if possible. The NCM continues working with patients in the STOP condition throughout their 12 months of study participation. Following the initial visit with the NCM, the frequency of visits depends on patient participant needs.

Primary outcomes

  1. 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

  1. Days of Risky Opioid Use in Past 180 Days

    Time frame: Month 7 up to Month 12

    Self-reported number of days of risky (illicit or nonmedical) opioid use in the past 180 days, assessed at 12 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 months 7-12.

  2. Days of Benzodiazepine Use in Past 180 Days

    Time frame: Up to Month 6

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days 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).

  3. Days of Benzodiazepine Use in Past 180 Days

    Time frame: Month 7 up to Month 12

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12.

  4. Days of Stimulant Use in Past 180 Days

    Time frame: Up to Month 6

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days 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).

  5. Days of Stimulant Use in Past 180 Days

    Time frame: Month 7 up to Month 12

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12 (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).

  6. Days of Marijuana Use in Past 180 Days

    Time frame: Up to Month 6

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days 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).

  7. Days of Marijuana Use in Past 180 Days

    Time frame: Month 7 up to Month 12

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12(i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).

  8. Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.

    Time frame: Up to Month 6

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days 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).

  9. Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.

    Time frame: Month 7 up to Month 12

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12 (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180).

  10. Days of Binge Alcohol Use in Past 180 Days

    Time frame: Up to Month 6

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days 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). Binge alcohol use defined as 5+ drinks/day for men under age 65 and 4+ drinks/day for women and men age 65 and over.

  11. Days of Binge Alcohol Use in Past 180 Days

    Time frame: Month 7 up to Month 12

    Measures of substance use are calculated as the sum of consecutive assessments of days of use in the past 30 days for months 7-12 (i.e., the sum of days of use from the measures collected on days 30, 60 90, 120, 150 and 180). Binge alcohol use defined as 5+ drinks/day for men under age 65 and 4+ drinks/day for women and men age 65 and over.

  12. Number of Participants With Opioid Use Disorder

    Time frame: Month 6

    Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).

  13. Number of Participants With Opioid Use Disorder

    Time frame: Month 12

    Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).

  14. Number of Participants With Drug (Other Than Opioid) Use Disorder

    Time frame: Month 6

    Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).

  15. Number of Participants With Drug (Other Than Opioid) Use Disorder

    Time frame: Month 12

    Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).

  16. Number of Participants With Alcohol Use Disorder

    Time frame: Month 6

    Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).

  17. Number of Participants With Alcohol Use Disorder

    Time frame: Month 12

    Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).

  18. Change in Overdose Risk Behavior Questionnaire Score

    Time frame: Baseline, Month 6

    13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.

  19. Change in Overdose Risk Behavior Questionnaire Score

    Time frame: Baseline, Month 12

    13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.

  20. Episodes of Non-Fatal Overdose

    Time frame: Month 6

    Number of non-fatal drug or alcohol overdoses per participant.

  21. Episodes of Non-Fatal Overdose

    Time frame: Month 12

    Number of non-fatal drug or alcohol overdoses per participant.

  22. Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity

    Time frame: Month 6

    Items 3-6 from the BPI short form will be completed to assess pain severity. Items 3-6 are rated on a Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain severity.

  23. Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity

    Time frame: Month 12

    Items 3-6 from the BPI short form will be completed to assess pain severity. Items 3-6 are rated on a Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain severity.

  24. Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference

    Time frame: Month 6

    Items 9A-9G from the BPI short form will be completed to assess pain interference. Items 9A-9G are rated on a Likert scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain interference.

  25. Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference

    Time frame: Month 12

    Items 9A-9G from the BPI short form will be completed to assess pain interference. Items 9A-9G are rated on a Likert scale from 0 (does not interfere) to 10 (completely interferes). The total score is the average of the response scores and ranges from 0-10; higher scores indicate greater pain interference.

  26. Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score

    Time frame: Month 6

    The PROMIS Anxiety Short Form comprises 8 questions assessing anxiety. Each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses and ranges from 8 to 40. The raw score is converted to a standardized t-score ranging from 0-100 with a mean of 50 and a standard deviation of 10. Higher t-scores indicate greater levels of anxiety.

  27. PROMIS Anxiety Short Form Score

    Time frame: Month 12

    The PROMIS Anxiety Short Form comprises 8 questions assessing anxiety. Each item is rated on a scale from 1 (never) to 5 (always). The raw score is the sum of responses and ranges from 8 to 40. The raw score is converted to a standardized t-score ranging from 0-100 with a mean of 50 and a standard deviation of 10. Higher t-scores indicate greater levels of anxiety.

  28. Patient Health Questionnaire-8 (PHQ-8) Score

    Time frame: Month 6

    The Patient Health Questionnaire-8 (PHQ-8) is a self-reported questionnaire that measures depressive symptoms. The PHQ-8 score is calculated by adding up the scores from each of the eight items on the questionnaire. The score ranges from 0 to 24, with higher scores indicating more severe depression.

  29. Patient Health Questionnaire-8 (PHQ-8) Score

    Time frame: Month 12

    The Patient Health Questionnaire-8 (PHQ-8) is a self-reported questionnaire that measures depressive symptoms. The PHQ-8 score is calculated by adding up the scores from each of the eight items on the questionnaire. The score ranges from 0 to 24, with higher scores indicating more severe depression.

  30. Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)

    Time frame: Month 6

    Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Physical Component Summary (PCS) subscale comprises physical health-related questions in the SF-12. The PCS raw score is the sum of responses. The PCS raw score is converted into a total score ranging from 0-100; higher scores indicate better physical health.

  31. Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)

    Time frame: Month 12

    Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Physical Component Summary (PCS) subscale comprises physical health-related questions in the SF-12. The PCS raw score is the sum of responses. The PCS raw score is converted into a total score ranging from 0-100; higher scores indicate better physical health.

  32. Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)

    Time frame: Month 6

    Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Mental Component Summary (MCS) subscale comprises mental health-related questions in the SF-12. The MCS raw score is the sum of responses. The MCS raw score is converted into a total score ranging from 0-100; higher scores indicate better mental health.

  33. Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)

    Time frame: Month 12

    Health-Related Quality of Life (SF-12) is a 12-item assessment of quality of life. The Mental Component Summary (MCS) subscale comprises mental health-related questions in the SF-12. The MCS raw score is the sum of responses. The MCS raw score is converted into a total score ranging from 0-100; higher scores indicate better mental health.

  34. Number of Acute Care Events

    Time frame: Up to Month 6

    Measured as the total number of self-reported emergency department (ED) visits in the past six months.

  35. Number of Acute Care Events

    Time frame: Month 7 up to Month 12

    Measured as the total number of self-reported emergency department (ED) visits in the past six months.

  36. Number of Acute Care Events (Self-Report)

    Time frame: Up to Month 6

    Measured as the total number of self-reported hospital utilizations in the past six months.

  37. Number of Acute Care Events (Self-Report)

    Time frame: Month 7 up to Month 12

    Measured as the total number of self-reported hospital utilizations in the past six months.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 6, 2020
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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