Opioid-use DisorderNCT04218201

Subthreshold Opioid Use Disorder Prevention (STOP) Trial

A study testing PCP brief advice, Video doctor and Telephone health coaching in people with Opioid-use Disorder, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid-use Disorder
What is being tested?: PCP brief advice, Video doctor and Telephone health coaching
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 321 participants
Where: 1 siteUnited States
Study dates: 25 Mar 2020to 17 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

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.

Read the 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.

Conditions: Opioid-use Disorder
Being tested: PCP brief advice, Video doctor, Telephone health coaching, Nurse Care Manager (NCM) intervention
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PCP brief adviceBehavioural
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 doctorBehavioural
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 coachingBehavioural
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) interventionBehavioural
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.

Study groups in NCT04218201
Study group	Role	What they receive
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention	Experimental	At baseline, patient participants in the STOP arm will receive the intervention components of brief advice from their PCP and a video doctor , printed educational materials, interaction with the NCM, and telephone health coaching. 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. During the baseline visit, patient participants also meet with the research staff to view a video on tablet or desktop computer that reinforces the PCP's counseling. Receives: Behavioral: PCP brief advice; Behavioral: Video doctor; Behavioral: Telephone health coaching; Behavioral: Nurse Care Manager (NCM) intervention
Enhanced Usual Care (EUC)	No intervention	PCPs will conduct primary care as usual, without the support of the NCM. At the baseline visit, patient participants receive an educational pamphlet and view a short video on overdose and cancer screening. The pamphlet includes information about preventing opioid-related overdose, including how to obtain a naloxone kit. The video content will feature the health benefits of exercise. It will be viewed on a tablet or desktop computer and will be approximately 2 minutes long. All EUC patient participants receive the same video, which is not tailored to the responses given on their questionnaires. There is no study intervention after the baseline visit.

What is being measured

The primary outcome is the main question the study is designed to answer.

Days of Risky Opioid Use in Past 180 Days
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).
Measured: Up to Month 6

Secondary outcomes (37)

Days of Risky Opioid Use in Past 180 Days
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.
Measured: Month 7 up to Month 12
Days of Benzodiazepine Use in Past 180 Days
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).
Measured: Up to Month 6
Days of Benzodiazepine Use in Past 180 Days
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.
Measured: Month 7 up to Month 12
Days of Stimulant Use in Past 180 Days
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).
Measured: Up to Month 6
Days of Stimulant Use in Past 180 Days
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).
Measured: Month 7 up to Month 12
Days of Marijuana Use in Past 180 Days
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).
Measured: Up to Month 6
Days of Marijuana Use in Past 180 Days
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).
Measured: Month 7 up to Month 12
Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.
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).
Measured: Up to Month 6
Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.
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).
Measured: Month 7 up to Month 12
Days of Binge Alcohol Use in Past 180 Days
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.
Measured: Up to Month 6
Days of Binge Alcohol Use in Past 180 Days
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.
Measured: Month 7 up to Month 12
Number of Participants With Opioid Use Disorder
Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).
Measured: Month 6
Number of Participants With Opioid Use Disorder
Opioid use disorder is assessed using the opioid items from the modified World Mental Health Composite International Diagnostic Interview (CIDI).
Measured: Month 12
Number of Participants With Drug (Other Than Opioid) Use Disorder
Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Measured: Month 6
Number of Participants With Drug (Other Than Opioid) Use Disorder
Drug use disorder is assessed using the drug items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Measured: Month 12
Number of Participants With Alcohol Use Disorder
Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Measured: Month 6
Number of Participants With Alcohol Use Disorder
Alcohol use disorder is assessed using the alcohol items from the Psychiatric Diagnostic Screening Questionnaire (PDSQ).
Measured: Month 12
Change in Overdose Risk Behavior Questionnaire Score
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.
Measured: Baseline, Month 6
Change in Overdose Risk Behavior Questionnaire Score
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.
Measured: Baseline, Month 12
Episodes of Non-Fatal Overdose
Number of non-fatal drug or alcohol overdoses per participant.
Measured: Month 6
Episodes of Non-Fatal Overdose
Number of non-fatal drug or alcohol overdoses per participant.
Measured: Month 12
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity
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.
Measured: Month 6
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity
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.
Measured: Month 12
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference
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.
Measured: Month 6
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference
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.
Measured: Month 12
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score
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.
Measured: Month 6
PROMIS Anxiety Short Form Score
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.
Measured: Month 12
Patient Health Questionnaire-8 (PHQ-8) Score
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.
Measured: Month 6
Patient Health Questionnaire-8 (PHQ-8) Score
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.
Measured: Month 12
Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)
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.
Measured: Month 6
Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)
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.
Measured: Month 12
Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)
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.
Measured: Month 6
Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)
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.
Measured: Month 12
Number of Acute Care Events
Measured as the total number of self-reported emergency department (ED) visits in the past six months.
Measured: Up to Month 6
Number of Acute Care Events
Measured as the total number of self-reported emergency department (ED) visits in the past six months.
Measured: Month 7 up to Month 12
Number of Acute Care Events (Self-Report)
Measured as the total number of self-reported hospital utilizations in the past six months.
Measured: Up to Month 6
Number of Acute Care Events (Self-Report)
Measured as the total number of self-reported hospital utilizations in the past six months.
Measured: Month 7 up to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 202017 May 2024

First posted6 Jan 2020
Study start25 Mar 2020
Primary completion15 Nov 2023
Study completion17 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04218201
Sponsor's protocol ID: 19-00535
Status last verified: Jun 2025
First submitted: 23 Dec 2019
Last updated: 19 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification, with permission from the lead investigator.

Publications

Rostam-Abadi Y, Liebschutz JM, Subramaniam G, Stone R, Appleton N, Mazel S, Alexander K, Brill SB, Case A, Gelberg L, Gordon AJ, Hong H, Incze MA, Kawasaki SS, Kim T, Kline M, Lovejoy TI, McCormack J, Zhang S, McNeely J. Understanding the characteristics and comorbidities of primary care patients with risky opioid use: Baseline data from the multi-site "Subthreshold Opioid Use Disorder Prevention" (STOP) Trial. J Gen Intern Med. 2025 Sep;40(12):2906-2915. doi: 10.1007/s11606-025-09613-4. Epub 2025 Jun 2.
PubMed 40457116
Liebschutz JM, Subramaniam GA, Stone R, Appleton N, Gelberg L, Lovejoy TI, Bunting AM, Cleland CM, Lasser KE, Beers D, Abrams C, McCormack J, Potter GE, Case A, Revoredo L, Jelstrom EM, Kline MM, Wu LT, McNeely J. Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods. Addict Sci Clin Pract. 2023 Nov 18;18(1):70. doi: 10.1186/s13722-023-00424-8.
PubMed 37980494

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Subthreshold Opioid Use Disorder Prevention (STOP) Trial
ClinicalTrials.gov ID: NCT04218201
Acronym / sponsor ID: 19-00535
Conditions: Opioid-use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 25 Mar 2020 (actual)
Primary completion: 15 Nov 2023 (actual)
Study completion: 17 May 2024 (actual)
First posted: 6 Jan 2020 (actual)
Results: Posted 21 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention	Experimental	Behavioral: PCP brief advice, Behavioral: Video doctor, Behavioral: Telephone health coaching, Behavioral: Nurse Care Manager (NCM) interventionAt baseline, patient participants in the STOP arm will receive the intervention components of brief advice from their PCP and a video doctor , printed educational materials, interaction with the NCM, and telephone health coaching. 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. During the baseline visit, patient participants also meet with the research staff to view a video on tablet or desktop computer that reinforces the PCP's counseling.
Enhanced Usual Care (EUC)	No intervention	–PCPs will conduct primary care as usual, without the support of the NCM. At the baseline visit, patient participants receive an educational pamphlet and view a short video on overdose and cancer screening. The pamphlet includes information about preventing opioid-related overdose, including how to obtain a naloxone kit. The video content will feature the health benefits of exercise. It will be viewed on a tablet or desktop computer and will be approximately 2 minutes long. All EUC patient participants receive the same video, which is not tailored to the responses given on their questionnaires. There is no study intervention after the baseline visit.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PCP brief adviceBrief 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.	Behavioural	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention
Video doctorDuring 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.	Behavioural	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention
Telephone health coachingAll 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).	Behavioural	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention
Nurse Care Manager (NCM) interventionNCMs 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.	Behavioural	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention

Primary outcome

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).

37 secondary outcomes

Days of Risky Opioid Use in Past 180 Days
Time frame: Month 7 up to Month 12
Days of Benzodiazepine Use in Past 180 Days
Time frame: Up to Month 6
Days of Benzodiazepine Use in Past 180 Days
Time frame: Month 7 up to Month 12
Days of Stimulant Use in Past 180 Days
Time frame: Up to Month 6
Days of Stimulant Use in Past 180 Days
Time frame: Month 7 up to Month 12
Days of Marijuana Use in Past 180 Days
Time frame: Up to Month 6
Days of Marijuana Use in Past 180 Days
Time frame: Month 7 up to Month 12
Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.
Time frame: Up to Month 6
Days of Other Drug Use (Not Including Opioids, Benzodiazepines, Stimulants, and Marijuana) in Past 180 Days.
Time frame: Month 7 up to Month 12
Days of Binge Alcohol Use in Past 180 Days
Time frame: Up to Month 6
Days of Binge Alcohol Use in Past 180 Days
Time frame: Month 7 up to Month 12
Number of Participants With Opioid Use Disorder
Time frame: Month 6
Number of Participants With Opioid Use Disorder
Time frame: Month 12
Number of Participants With Drug (Other Than Opioid) Use Disorder
Time frame: Month 6
Number of Participants With Drug (Other Than Opioid) Use Disorder
Time frame: Month 12
Number of Participants With Alcohol Use Disorder
Time frame: Month 6
Number of Participants With Alcohol Use Disorder
Time frame: Month 12
Change in Overdose Risk Behavior Questionnaire Score
Time frame: Baseline, Month 6
Change in Overdose Risk Behavior Questionnaire Score
Time frame: Baseline, Month 12
Episodes of Non-Fatal Overdose
Time frame: Month 6
Episodes of Non-Fatal Overdose
Time frame: Month 12
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity
Time frame: Month 6
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Severity
Time frame: Month 12
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference
Time frame: Month 6
Brief Pain Inventory (BPI) Short Form Modified Score - Pain Interference
Time frame: Month 12
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form Score
Time frame: Month 6
PROMIS Anxiety Short Form Score
Time frame: Month 12
Patient Health Questionnaire-8 (PHQ-8) Score
Time frame: Month 6
Patient Health Questionnaire-8 (PHQ-8) Score
Time frame: Month 12
Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)
Time frame: Month 6
Health-Related Quality of Life (SF-12) - Physical Component Summary (PCS)
Time frame: Month 12
Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)
Time frame: Month 6
Health-Related Quality of Life (SF-12) - Mental Component Summary (MCS)
Time frame: Month 12
Number of Acute Care Events
Time frame: Up to Month 6
Number of Acute Care Events
Time frame: Month 7 up to Month 12
Number of Acute Care Events (Self-Report)
Time frame: Up to Month 6
Number of Acute Care Events (Self-Report)
Time frame: Month 7 up to Month 12

Results and safety

Results posted to the registry on 21 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention - Patients	88	79
STOP Intervention - Primary Care Providers (PCPs)	58	49
Enhanced Usual Care (EUC) - Patients	114	109
EUC - PCPs	61	55

Primary outcome: Days of Risky Opioid Use in Past 180 Days

Time frame: Up to Month 6. Mean (Standard Deviation). Unit: days

Measure	Subthreshold Opioid Use Disorder Prevention(STOP) Intervention n = 75	Enhanced Usual Care (EUC) n = 101
Value	12.2 (27.73)	15.5 (32.64)

37 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed among patient participants nor PCPs. All-cause mortality was assessed among patient participants, but not among PCPs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subthreshold Opioid Use Disorder Prevention(STOP) Intervention	0 of 0	0 of 0	0 of 88
Enhanced Usual Care (EUC)	0 of 0	0 of 0	2 of 114

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40457116Rostam-Abadi Y, Liebschutz JM, Subramaniam G, Stone R, Appleton N, Mazel S, Alexander K, Brill SB, Case A, Gelberg L, Gordon AJ, Hong H, Incze MA, Kawasaki SS, Kim T, Kline M, Lovejoy TI, McCormack J, Zhang S, McNeely J. Understanding the characteristics and comorbidities of primary care patients with risky opioid use: Baseline data from the multi-site "Subthreshold Opioid Use Disorder Prevention" (STOP) Trial. J Gen Intern Med. 2025 Sep;40(12):2906-2915. doi: 10.1007/s11606-025-09613-4. Epub 2025 Jun 2.
Derived from this study: PubMed 37980494Liebschutz JM, Subramaniam GA, Stone R, Appleton N, Gelberg L, Lovejoy TI, Bunting AM, Cleland CM, Lasser KE, Beers D, Abrams C, McCormack J, Potter GE, Case A, Revoredo L, Jelstrom EM, Kline MM, Wu LT, McNeely J. Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods. Addict Sci Clin Pract. 2023 Nov 18;18(1):70. doi: 10.1186/s13722-023-00424-8.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, with permission from the lead investigator.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer McNeely, MD principal investigator

NYU Langone

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PCP brief advice, Video doctor and Telephone health coaching in people with Opioid-use Disorder, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days of Risky Opioid Use in Past 180 Days (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04218201, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.