Subthreshold Opioid Use Disorder Prevention (STOP) Trial

NCT04218201 | Completed Results DMC

• 1 other identifier: 19-00535
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to Month 6

Secondary Outcomes (37)

• Days of Risky Opioid Use in Past 180 Days

  Month 7 up to Month 12

• Days of Benzodiazepine Use in Past 180 Days

  Up to Month 6

• Days of Benzodiazepine Use in Past 180 Days

  Month 7 up to Month 12

• Days of Stimulant Use in Past 180 Days

  Up to Month 6

• Days of Stimulant Use in Past 180 Days

  Month 7 up to Month 12

Study Arms (2)

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.

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.

Interventions

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.

Subthreshold Opioid Use Disorder Prevention(STOP) Intervention

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.

Subthreshold Opioid Use Disorder Prevention(STOP) Intervention

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).

Subthreshold Opioid Use Disorder Prevention(STOP) Intervention

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.

Subthreshold Opioid Use Disorder Prevention(STOP) Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Planning to resign from the clinic in the next 24 months, per PCP self-report.
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 40457116 DERIVED

• 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.

  PMID: 37980494 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Rebecca Stone
• Organization: NYU Langone Health

Rebecca.Stone@nyulangone.org

646-754-5322

Study Officials

• Jennifer McNeely, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 6, 2020
• Study Start: March 25, 2020
• Primary Completion: November 15, 2023
• Study Completion: May 17, 2024
• Last Updated: June 19, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sets for CTN protocols will be available after (1) the primary paper has been accepted for publication, or (2) the data is locked for more than 18 months, whichever comes first
• Access Criteria: Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (https://datashare.nida.nih.gov/).

Locations

US (1)