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.

Study Overview

• Status: Active, not recruiting
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Behavioral: PCP brief advice; Behavioral: Video doctor; Behavioral: Telephone health coaching; Behavioral: Nurse Care Manager (NCM) intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Stone; Phone Number: 646-754-5322; Email: Rebecca.Stone@nyulangone.org
• Study Contact Backup: Name: Noa Appleton; Phone Number: 646-501-3561; Email: Noa.Appleton@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subthreshold Opioid Use Disorder Prevention(STOP) Intervention; 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; 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.; Behavioral: Video doctor; 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.; Behavioral: Telephone health coaching; 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).; Behavioral: Nurse Care Manager (NCM) intervention; 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.
No Intervention: Enhanced Usual Care (EUC); 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of days of Opioid use	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. Participants are asked to specify the number of days of illicit opioid use and of nonmedical opioid use in the past 30 days (range is 0-30 days). 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 .	6 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Substance use disorder	Opioid use disorder is assessed at baseline and at 12 months using the modified World Mental Health Composite International Diagnostic Interview (CIDI). Drug and alcohol use disorder measures are collected using the Psychiatric Diagnostic Screening Questionnaire (PDSQ) at baseline and at 6 and 12 months. The PDSQ is a brief self-administered instrument to assess DSM-4 Axis I disorders, including alcohol use disorder (AUD) and drug use disorder (DUD). It is the only brief questionnaire assessing DSM-4 substance use disorder that has been validated for self-administration. The PDSQ was validated in more than 3,000 in both medical and mental health outpatient settings.There are 6 items assessing AUD and 6 items for DUD, all using a yes/no response format and a 2-week timeframe. The PDSQ is used for baseline and follow-up assessments of AUD, DUD, and depression. Because the PDSQ does not specify drug class the CIDI, rather than the PDSQ, is used to measure DSM-5 OUD.	Screening/Baseline, 6 months and 12 months
Change in Overdose risk behaviors and events	Measured using the Overdose Risk Behavior Questionnaire to assess Overdose risk behavior and behavioral intention to reduce risk.Overdose risk behavior is assessed using a 9-item self-administered questionnaire that was developed by a group of opioid researchers based on knowledge of overdose behavioral risk factors, and used in 3 prior studies to capture overdose risk behavior. These questions measure the frequency, in the past 3 months, at which individuals used alone; used in a new place/environment; used other substances (alcohol, benzodiazepines, stimulants) within 2 hours of opioids; used more than one opioid; used more than the usual amount; and used inhaled or injected opioids. The total risk score is an aggregation of responses to the individual questions. The overdose risk behavior questionnaire is self-administered.	at baseline and at 6 and 12 months
Change in Pain symptoms and pain-related functioning	Pain symptoms (severity, impact on functioning) are measured at baseline and at 3, 6, 9, and 12 months using the Brief Pain Inventory Short Form (BPI) short form items on pain and functioning. The BPI short form is widely used to measure clinical pain for clinical and research purposes. The 15-item self-administered questionnaire measures the "sensory" dimension of pain (intensity, or severity) and the "reactive" dimension of pain (interference with daily function) experienced in the past 24 hours. The form asks a series of questions to measure the intensity of pain, and the rate at which pain interferes with daily activities, using a 0 to 10 scale. The BPI short form has been validated as a tool to assess the severity of pain and the impact pain has on an individual's quality of life.	Baseline, at 3, 6, 9 and 12 months
Change in Mental health	Anxiety symptoms are measured at baseline and 6 and 12 months. Depression symptoms are measured at baseline and at 6 and 12 months (PHQ-8 ). Assessment of depression symptoms is accomplished with the Patient Health Questionnaire (PHQ-8) depression screening tool. The ninth item of the PHQ-9 is about suicidal ideation, which is queried separately in our study as part of the Patient Safety Screener (PSS). The PHQ-8 has been validated as a measure of depression, independent of the PHQ- 9.	Baseline, at 6 and at 12 months
Change in Mental health	Anxiety symptoms are measured at baseline and 6 and 12 months. Assessment of suicidal ideation is accomplished with the Patient Safety Screener (PSS). The ninth item of the Patient Health Questionnaire (PHQ-9) is about suicidal ideation, which is queried separately in our study as part of the PSS. The PSS is a validated screening instrument that was used in the ED-SAFE study. It consists of one item about suicidal ideation in the past two weeks, followed by one item about lifetime suicide attempts, in a yes/no format. Individuals reporting a suicide attempt are asked when this last occurred. The PSS is administered by research staff for safety reasons, to allow for rapid assessment and response for patients with suicidality.	Baseline, at 6 and at 12 months
Health-related quality of life	Health-Related Quality of Life (SF-12) is measured at baseline and at 6 and 12 months.The SF-12 is part of the CTN DSC recommended assessment battery that measures overall functional health and well-being. The questionnaire begins by asking to rate one's overall health on a scale of 1 to 5, followed by two items on daily living activities. Additional questions address physical and emotional health as well as pain interference during the past 4 weeks. The SF-12 is a validated tool for measuring health-related quality of life.	Baseline, at 6 and 12 months
Acute health care utilization	ED and hospital utilization is measured using participant self-report of acute care events, collected at baseline and at 6 and 12 months. Acute care admissions are a meaningful outcome for health systems and policymakers and will be measured using the CTN DSC questionnaire. Patient participants will report the number of ED visits and number of hospitalizations in the past 6 months. For any reported hospitalization, days in the hospital will be asked.	Baseline, at 6 and 12 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jennifer McNeely, MD, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Actual): November 15, 2023
• Study Completion (Estimated): May 15, 2024

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 19-00535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification, with permission from the lead investigator.
• IPD Sharing 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
• IPD Sharing Access Criteria: Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (https://datashare.nida.nih.gov/).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No