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Substance UseNCT06116266

Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)

A study testing Education and support for primary care providers (PCPS), Nurse Care Manager (NCM) visits and Addiction specialist consultant in people with Substance Use, run by NYU Langone Health at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this trial is to test the efficacy of a collaborative care intervention to address opioid- and/or stimulant-involved polysubstance use in adult primary care patients with moderate to severe substance use disorders (SUD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance Use
What is being tested?
Education and support for primary care providers (PCPS), Nurse Care Manager (NCM) visits and Addiction specialist consultant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
8 sitesUnited States
Study dates
31 Jan 2025to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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, NP, PA) who is able to prescribe controlled substances (Schedule III), or medical trainee meeting the requirements below.
  • Serves as a primary care provider to adult patients (18 years of age and over) of the study clinic(s) during direct patient care sessions.
  • Willing to be randomized to either of the study conditions. a. Medical trainees (physicians who are residents or fellows), are eligible if they have at least one continuity clinic session per week on average in the study clinic. Trainees must have plans to be working in a study clinic for approximately 8 months or longer. They must be able to provide prescriptions for controlled substances (Schedule III) either directly or through their preceptor(s).

Patient Inclusion Criteria:

  • The participant's PCP is enrolled in the study.
  • Age 18 years or older.
  • Spoken and written proficiency in language of study materials, as determined by patient self-report and research staff evaluation.
  • Moderate to severe substance use disorder for opioids, stimulants, and/or alcohol, (defined as meeting four or more DSM-5 criteria per substance as measured on the CIDI-adapted for DSM-5).
  • a) Patients having alcohol use disorder without an opioid or stimulant SUD are required to have current opioid or stimulant use, as measured on the TAPS tool or baseline monthly survey.
  • Current polysubstance use, defined as self-reported use of two or more substances of concern in the past 30 days, at least one of which is required to be an opioid or stimulant. Substances of concern include opioids (illicit opioids, nonmedical use of prescription opioids), stimulants (cocaine, methamphetamine), alcohol (heavy drinking defined as more than 5 for men and 4 for women drinks on a single occasion), and benzodiazepines (nonmedical use). Nonmedical use includes using prescription medications more than prescribed, or that were not prescribed to the individual taking them.
  • Patients must report on the baseline monthly survey use in the past 30 days of at least one substance at or above the following thresholds: >10 days for opioids; >10 days for alcohol heavy drinking; >7 days for stimulants. These minimum thresholds reflect levels of use that are typical for individuals with moderate to severe SUD, and are lower for stimulants than for opioids and alcohol to reflect the different patterns of use that are observed in prior trials.
  • Access to a reliable cell phone or willing to accept a phone as part of the incentive for completing the baseline visit (as determined by patient self-report).
  • Able to provide sufficient contact information (minimum of one locator).
  • Willing and able to provide written informed consent.

PCP Exclusion Criteria:

  • Definite plan to resign from the clinic in the next eight months, per PCP self-report. Residents and fellows will need at least eight months before training completion to enroll.

Patient Exclusion Criteria:

  • Currently being treated with medication for OUD (MOUD), and do not have moderate to severe AUD or StUD
  • Initiated MOUD treatment (buprenorphine, methadone, or XR-NTX) within the 30 days prior to screening, per patient self-report. Because substance use may fall rapidly with the initiation of MOUD, patients who recently started MOUD may already be in the process of making changes to their substance use that are not attributable to the intervention.
  • a) Initiation is defined as starting a new MOUD treatment episode, after not receiving MOUD treatment in the prior 30 days
  • Initiated a SUD treatment program within the 30 days prior to screening, per patient self-report. Because substance use may fall rapidly with the initiation of a treatment program, patients who recently initiated treatment may already be making changes to their substance use that are not attributable to the intervention. SUD treatment program includes outpatient or residential programs for alcohol/drug treatment; does not include detox or short-term inpatient episodes (<15 days), or peer support (e.g., 12-Step Program such as AA/NA, Smart Recovery)
  • a) Initiation is defined as starting a new treatment episode, after not being in a SUD treatment program in the prior 30 days
  • Pregnancy, as determined by patient self-report.
  • 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
  • Definite plan to leave the area or the clinical practice within the next six 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 (e.g. unstable/severe acute mental illness).

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites
  • Sea Mar Community Health Centers

    Bellingham, Washington, 98226

  • Winding Waters Medical Clinic

    Enterprise, Oregon, 97828

  • Harris Health

    Houston, Texas, 77030

  • Union Community Care

    Lancaster, Pennsylvania, 17603

  • Wisconsin Research & Education Network

    Madison, Wisconsin, 53705

  • NYU Langone Health

    New York, New York, 10016

  • The Institute for Family Health

    New York, New York, 10025

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

Other trials in United States

About this study

Official title: NIDA CTN Protocol 0139: Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)

The purpose of this trial is to test the efficacy of a collaborative care intervention to address opioid- and/or stimulant-involved polysubstance use in adult primary care patients with moderate to severe substance use disorders (SUD). The primary aims are to reduce days of opioid use (illicit or nonmedical opioid use), days of illicit stimulant use (cocaine, methamphetamine), and days of heavy alcohol use.

Conditions
Substance Use
Being tested
Education and support for primary care providers (PCPS), Nurse Care Manager (NCM) visits, Addiction specialist consultant, Health coaching sessions, Patient educational materials
Medical subject headings
Substance-Related Disorders

What participants receive

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

  • Education and support for primary care providers (PCPS)Other

    All PCPs in the EUC and Co-Care arms receive brief education on SUD treatment, including medications for OUD and AUD and contingency management for StUD, and recognizing and counteracting stigma while caring for patients with SUD.

  • Nurse Care Manager (NCM) visitsOther

    A full-time clinic-embedded nurse care manager who works with patients and their PCPs to facilitate and support patient engagement in evidence-based treatment for polysubstance use and management of associated health conditions

  • Addiction specialist consultantOther

    An addiction specialist consultant who supports the nurse care manager and PCP in formulating and adjusting treatment plans

  • Health coaching sessionsOther

    Health coaches who use motivational interviewing and cognitive behavioral therapy to motivate and support patients in behavior change to reduce polysubstance use-related harms. Patients may receive up to 12 health coaching sessions in total. The sessions will occur via phone and/or HIPAA compliant video chat software.

  • Patient educational materialsOther

    Patient participants receive an educational pamphlet addressing overdose prevention, information about accessing naloxone, and local SUD treatment options.

Study groups in NCT06116266
Study groupRoleWhat they receive
Co-CareExperimentalPatient participants with providers will receive primary care treatment plus the full Co-Care intervention which includes: Nurse Care Manager (NCM) visits, Addiction specialist consultations through NCM if indicated, and Health coaching sessions.
Receives: Other: Education and support for primary care providers (PCPS); Other: Nurse Care Manager (NCM) visits; Other: Addiction specialist consultant; Other: Health coaching sessions
Enhanced Usual Care (EUC)Active comparatorPatient participants with providers will receive primary care treatment as usual plus educational materials.
Receives: Other: Education and support for primary care providers (PCPS); Other: Patient educational materials

What is being measured

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

  1. Total days of use of opioids, stimulants, and alcohol heavy drinking

    Days of opioid use are defined as days with any use of heroin or synthetic opioids, or nonmedical use of prescription opioids. Nonmedical use includes using prescription opioids more than prescribed (e.g., taking two tablets when the prescription indicates a dose of one tablet) or taking pharmaceutical opioids that were not prescribed to the individual taking them. Days of stimulant use are defined as days with any use of cocaine or methamphetamine. Days of alcohol heavy drinking are defined as days with 5+ drinks/day for men, 4+ drinks/day for women.

    This outcome measure is collected using single item questions based on the Addiction Severity Index.

    Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form.

    Measured: Month 4-6

Secondary outcomes (68)
  1. Treatment Effectiveness Assessment (TEA) total score

    The Treatment Effectiveness Assessment (TEA) is a 4-item patient-reported outcome measure of progress in treatment and recovery in the four following domains: substance use, health, lifestyle, and community involvement. Each domain is assessed with a single item and scored on a scale of 1-10 (higher scores indicate better progress). The total score is calculated using the sum of numerical responses for the four domains and can range from four (not well at all on all domains) to 40 (extremely well on all domains).

    Measured: Baseline

  2. Treatment Effectiveness Assessment (TEA) total score

    The Treatment Effectiveness Assessment (TEA) is a 4-item patient-reported outcome measure of progress in treatment and recovery in the four following domains: substance use, health, lifestyle, and community involvement. Each domain is assessed with a single item and scored on a scale of 1-10 (higher scores indicate better progress). The total score is calculated using the sum of numerical responses for the four domains and can range from four (not well at all on all domains) to 40 (extremely well on all domains).

    Measured: Month 3

  3. Treatment Effectiveness Assessment (TEA) total score

    The Treatment Effectiveness Assessment (TEA) is a 4-item patient-reported outcome measure of progress in treatment and recovery in the four following domains: substance use, health, lifestyle, and community involvement. Each domain is assessed with a single item and scored on a scale of 1-10 (higher scores indicate better progress). The total score is calculated using the sum of numerical responses for the four domains and can range from four (not well at all on all domains) to 40 (extremely well on all domains).

    Measured: Month 6

  4. Treatment Effectiveness Assessment (TEA) total score

    The Treatment Effectiveness Assessment (TEA) is a 4-item patient-reported outcome measure of progress in treatment and recovery in the four following domains: substance use, health, lifestyle, and community involvement. Each domain is assessed with a single item and scored on a scale of 1-10 (higher scores indicate better progress). The total score is calculated using the sum of numerical responses for the four domains and can range from four (not well at all on all domains) to 40 (extremely well on all domains).

    Measured: Month 12

  5. Total days of use of opioids, stimulants, and alcohol

    Days of opioid use are defined as days with any use of heroin or synthetic opioids, or nonmedical use of prescription opioids. Nonmedical use includes using prescription opioids more than prescribed (e.g., taking two tablets when the prescription indicates a dose of one tablet) or taking pharmaceutical opioids that were not prescribed to the individual taking them. Days of stimulant use are defined as days with any use of cocaine or methamphetamine. Days of alcohol heavy drinking are defined as days with 5+ drinks/day for men, 4+ drinks/day for women.

    This outcome measure is collected using single item questions based on the Addiction Severity Index. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form.

    Measured: Months 10-12

  6. Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol

    Days of abstinence from substances of concern is measured as part of the Addiction Severity Index. At the end of the substance specific questions, patient participants who reported use of more than one substance of concern will be asked: "On how many days did you use none of these [insert names of all substances with 1+ days of use reported]?" (range is 0-30 days). For participants reporting use of 0-1 substances of concern, days of abstinence is calculated as 30 minus [number of days reported].

    Measured: Month 6

  7. Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol

    Days of abstinence from substances of concern is measured as part of the Addiction Severity Index. At the end of the substance specific questions, patient participants who reported use of more than one substance of concern will be asked: "On how many days did you use none of these [insert names of all substances with 1+ days of use reported]?" (range is 0-30 days). For participants reporting use of 0-1 substances of concern, days of abstinence is calculated as 30 minus [number of days reported].

    Measured: Month 12

  8. Number of days of nonmedical benzodiazepine use

    Nonmedical benzodiazepine use is defined as taking benzodiazepines that were not prescribed to the individual taking them.

    This outcome measure will be measured using single item questions based on the Addiction Severity Index. "During the past 30 days, on how many days did you use [substance name]?" The question will be asked separately for each substance type. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form.

    Measured: Baseline

  9. Number of days of nonmedical benzodiazepine use

    Nonmedical benzodiazepine use is defined as taking benzodiazepines that were not prescribed to the individual taking them.

    This outcome measure will be measured using single item questions based on the Addiction Severity Index. "During the past 30 days, on how many days did you use [substance name]?" The question will be asked separately for each substance type. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form.

    Measured: Months 4-6

  10. Number of days of nonmedical benzodiazepine use

    Nonmedical benzodiazepine use is defined as taking benzodiazepines that were not prescribed to the individual taking them.

    This outcome measure will be measured using single item questions based on the Addiction Severity Index. "During the past 30 days, on how many days did you use [substance name]?" The question will be asked separately for each substance type. Patient participants are asked to specify the number of days of use in the past 30 days (range is 0-30 days, value=0 for substances that were not used). The assessment is self-administered using a computerized form.

    Measured: Months 10-12

  11. Proportion of patients with receipt of a prescription for a medication used for SUD treatment

    Medication for SUD is defined as any medication for OUD, AUD, or StUD. This measures is collected from the electronic health record.

    Measured: Baseline

  12. Proportion of patients with receipt of a prescription for a medication used for SUD treatment

    Medication for SUD is defined as any medication for OUD, AUD, or StUD. This measures is collected from the electronic health record.

    Measured: Month 3

  13. Proportion of patients with receipt of a prescription for a medication used for SUD treatment

    Medication for SUD is defined as any medication for OUD, AUD, or StUD. This measures is collected from the electronic health record.

    Measured: Month 6

  14. Proportion of patients with receipt of a prescription for a medication used for SUD treatment

    Medication for SUD is defined as any medication for OUD, AUD, or StUD. This measures is collected from the electronic health record.

    Measured: Month 12

  15. Proportion of patients attending behavioral health visit(s) addressing substance use

    This measure is based on behavioral health visits addressing substance use that occurred in the study clinic(s), as documented in the electronic health record.

    Measured: Baseline

  16. Proportion of patients attending behavioral health visit(s) addressing substance use

    This measure is based on behavioral health visits addressing substance use that occurred in the study clinic(s), as documented in the electronic health record.

    Measured: Month 3

  17. Proportion of patients attending behavioral health visit(s) addressing substance use

    This measure is based on behavioral health visits addressing substance use that occurred in the study clinic(s), as documented in the electronic health record.

    Measured: Month 6

  18. Proportion of patients attending behavioral health visit(s) addressing substance use

    This measure is based on behavioral health visits addressing substance use that occurred in the study clinic(s), as documented in the electronic health record.

    Measured: Month 12

  19. OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire

    The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The OUD category in the questionnaire is comprised of 15 yes/no items. The OUD symptom score is calculated by finding the sum of the items marked "Yes". OUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder).

    Measured: Baseline

  20. OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire

    The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The OUD category in the questionnaire is comprised of 15 yes/no items. The OUD symptom score is calculated by finding the sum of the items marked "Yes". OUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder).

    Measured: Month 6

  21. StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire

    The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The StUD category in the questionnaire is comprised of 15 yes/no items. The StUD symptom score is calculated by finding the sum of the items marked "Yes". StUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder).

    Measured: Baseline

  22. StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire

    The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The StUD category in the questionnaire is comprised of 15 yes/no items. The StUD symptom score is calculated by finding the sum of the items marked "Yes". StUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder).

    Measured: Month 6

  23. AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire

    The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The AUD category in the questionnaire is comprised of 15 yes/no items. The AUD symptom score is calculated by finding the sum of the items marked "Yes". AUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder).

    Measured: Baseline

  24. AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire

    The CIDI questionnaire measures severity of symptoms for three categories of substance use disorders (SUD); OUD, StUD, and AUD. The AUD category in the questionnaire is comprised of 15 yes/no items. The AUD symptom score is calculated by finding the sum of the items marked "Yes". AUD scores are interpreted as follows: 0-1 (subthreshold), 2-3 (mild use disorder), 4-5 (moderate use disorder), and 6+ (severe use disorder).

    Measured: Month 6

  25. Overdose Risk Behavior Questionnaire score

    The Overdose Risk Behavior Questionnaire is a 9-item self-administered questionnaire. These questions measure the frequency, in the past 6 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. Response options were "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)," except for #6, which was "never (0)," "once (1)," or "more than once (2)." The total risk score is an aggregation of responses to the individual questions. Sum score range: 0-32, higher scores indicate greater risk of overdose.

    Measured: Baseline

  26. Overdose Risk Behavior Questionnaire score

    The Overdose Risk Behavior Questionnaire is a 9-item self-administered questionnaire. These questions measure the frequency, in the past 6 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. Response options were "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)," except for #6, which was "never (0)," "once (1)," or "more than once (2)." The total risk score is an aggregation of responses to the individual questions. Sum score range: 0-32, higher scores indicate greater risk of overdose.

    Measured: Month 6

  27. Overdose Risk Behavior Questionnaire score

    The Overdose Risk Behavior Questionnaire is a 9-item self-administered questionnaire. These questions measure the frequency, in the past 6 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. Response options were "never (0)," "rarely (1)," "sometimes (2)," "often (3)," and "very often (4)," except for #6, which was "never (0)," "once (1)," or "more than once (2)." The total risk score is an aggregation of responses to the individual questions. Sum score range: 0-32, higher scores indicate greater risk of overdose.

    Measured: Month 12

  28. Number of episodes of a non-fatal overdose

    Outcome measure is self reported on the Non-Fatal Overdose Questionnaire.

    Measured: Baseline

  29. Number of episodes of a non-fatal overdose

    Outcome measure is self reported on the Non-Fatal Overdose Questionnaire.

    Measured: Month 6

  30. Number of episodes of a non-fatal overdose

    Outcome measure is self reported on the Non-Fatal Overdose Questionnaire.

    Measured: Month 12

  31. World Health Organization Quality of Life (WHOQOL-BREF) score

    The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Higher scores denote higher QOL.

    Measured: Baseline

  32. World Health Organization Quality of Life (WHOQOL-BREF) score

    The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Higher scores denote higher QOL.

    Measured: Month 3

  33. World Health Organization Quality of Life (WHOQOL-BREF) score

    The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Higher scores denote higher QOL.

    Measured: Month 6

  34. World Health Organization Quality of Life (WHOQOL-BREF) score

    The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. The mean score of items within each domain is used to calculate the domain score. After computed the scores, they transformed linearly to a 0-100-scale. Higher scores denote higher QOL.

    Measured: Month 12

  35. Single-item general health question (HRQOL-1) score

    Questionnaire consist of one question 'Would you say that in general your health is' [scaled response ranges from (5)Excellent, (4)Very good, (3)Good, (2)Fair or (1)Poor]. The higher the score the better the patient's general health.

    Measured: Baseline

  36. Single-item general health question (HRQOL-1) score

    Questionnaire consist of one question 'Would you say that in general your health is' [scaled response ranges from (5)Excellent, (4)Very good, (3)Good, (2)Fair or (1)Poor]. The higher the score the better the patient's general health.

    Measured: Month 3

  37. Single-item general health question (HRQOL-1) score

    Questionnaire consist of one question 'Would you say that in general your health is' [scaled response ranges from (5)Excellent, (4)Very good, (3)Good, (2)Fair or (1)Poor]. The higher the score the better the patient's general health.

    Measured: Month 6

  38. Single-item general health question (HRQOL-1) score

    Questionnaire consist of one question 'Would you say that in general your health is' [scaled response ranges from (5)Excellent, (4)Very good, (3)Good, (2)Fair or (1)Poor]. The higher the score the better the patient's general health.

    Measured: Month 12

  39. Patient Health Questionnaire (PHQ-8) score

    The Patient Health Questionnaire depression scale (PHQ-8) consists of 8 items. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

    Measured: Baseline

  40. Patient Health Questionnaire (PHQ-8) score

    The Patient Health Questionnaire depression scale (PHQ-8) consists of 8 items. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

    Measured: Month 3

  41. Patient Health Questionnaire (PHQ-8) score

    The Patient Health Questionnaire depression scale (PHQ-8) consists of 8 items. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

    Measured: Month 6

  42. Patient Health Questionnaire (PHQ-8) score

    The Patient Health Questionnaire depression scale (PHQ-8) consists of 8 items. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

    Measured: Month 12

  43. Percentage of participants with a negative suicidality screen

    Outcome measured by Ask Suicide-Screening Questions (ASQ). The ASQ consists of four yes/no questions. If patient answers "No" to all questions 1 through 4, they are considered negative for suicidality. If patient answers "Yes" to any of questions 1 through 4, or refuses to answer, they are considered a positive screen.

    Measured: Baseline

  44. Percentage of participants with a negative suicidality screen

    Outcome measured by Ask Suicide-Screening Questions (ASQ). The ASQ consists of four yes/no questions. If patient answers "No" to all questions 1 through 4, they are considered negative for suicidality. If patient answers "Yes" to any of questions 1 through 4, or refuses to answer, they are considered a positive screen.

    Measured: Month 3

  45. Percentage of participants with a negative suicidality screen

    Outcome measured by Ask Suicide-Screening Questions (ASQ). The ASQ consists of four yes/no questions. If patient answers "No" to all questions 1 through 4, they are considered negative for suicidality. If patient answers "Yes" to any of questions 1 through 4, or refuses to answer, they are considered a positive screen.

    Measured: Month 6

  46. Percentage of participants with a negative suicidality screen

    Outcome measured by Ask Suicide-Screening Questions (ASQ). The ASQ consists of four yes/no questions. If patient answers "No" to all questions 1 through 4, they are considered negative for suicidality. If patient answers "Yes" to any of questions 1 through 4, or refuses to answer, they are considered a positive screen.

    Measured: Month 12

  47. Generalized Anxiety Disorder (GAD-7) score

    The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The whole scale score can range from 0 to 21 Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

    Measured: Baseline

  48. Generalized Anxiety Disorder (GAD-7) score

    The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The whole scale score can range from 0 to 21 Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

    Measured: Month 3

  49. Generalized Anxiety Disorder (GAD-7) score

    The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The whole scale score can range from 0 to 21 Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

    Measured: Month 6

  50. Generalized Anxiety Disorder (GAD-7) score

    The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). The whole scale score can range from 0 to 21 Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.

    Measured: Month 12

  51. Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score

    PC-PTSD-5 consists of 5-items. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0 meaning no trauma exposure. If a respondent endorses a trauma exposure, they can score a 0-5 on the PC-PTSD-5, which is a count of "yes" responses to the 5 questions about how the trauma has affected them in the past month. Higher scores indicate the trauma exposure has often affected them over the past month.

    Measured: Baseline

  52. Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score

    PC-PTSD-5 consists of 5-items. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0 meaning no trauma exposure. If a respondent endorses a trauma exposure, they can score a 0-5 on the PC-PTSD-5, which is a count of "yes" responses to the 5 questions about how the trauma has affected them in the past month. Higher scores indicate the trauma exposure has often affected them over the past month.

    Measured: Month 3

  53. Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score

    PC-PTSD-5 consists of 5-items. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0 meaning no trauma exposure. If a respondent endorses a trauma exposure, they can score a 0-5 on the PC-PTSD-5, which is a count of "yes" responses to the 5 questions about how the trauma has affected them in the past month. Higher scores indicate the trauma exposure has often affected them over the past month.

    Measured: Month 6

  54. Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score

    PC-PTSD-5 consists of 5-items. If a respondent denies exposure, the PC-PTSD-5 is complete with a score of 0 meaning no trauma exposure. If a respondent endorses a trauma exposure, they can score a 0-5 on the PC-PTSD-5, which is a count of "yes" responses to the 5 questions about how the trauma has affected them in the past month. Higher scores indicate the trauma exposure has often affected them over the past month.

    Measured: Month 12

  55. Number of Patient Reported ED visits

    Measured: Baseline

  56. Number of Patient Reported ED visits

    Measured: Month 6

  57. Number of Patient Reported ED visits

    Measured: Month 12

  58. Number of patient reported hospital admissions

    Measured: Baseline

  59. Number of patient reported hospital admissions

    Measured: Month 6

  60. Number of patient reported hospital admissions

    Measured: Month 12

  61. Proportion of patients with a diagnosis of OUD receiving any medication for OUD treatment

    Measured: Month 12

  62. Proportion of patients with a diagnosis of AUD receiving any medication for AUD treatment

    Measured: Month 12

  63. PCPs Medical Condition Regard Scale (MCRS) score

    Medical Condition Regard Scale (MCRS) is a self-administered instrument examines the degree to which 12 medical conditions (including alcohol dependence and intravenous drug use) are enjoyable, treatable, and worthy of medical resources. Responses were measured on a six-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = not sure but probably disagree, 4 = not sure but probably agree, 5 = agree, and 6 = strongly agree. A MCRS score of >57 correlates with high probability of desire to care for patients with with drug and alcohol use.

    Measured: Baseline

  64. PCPs Medical Condition Regard Scale (MCRS) score

    Medical Condition Regard Scale (MCRS) is a self-administered instrument examines the degree to which 12 medical conditions (including alcohol dependence and intravenous drug use) are enjoyable, treatable, and worthy of medical resources. Responses were measured on a six-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = not sure but probably disagree, 4 = not sure but probably agree, 5 = agree, and 6 = strongly agree. A MCRS score of >57 correlates with high probability of desire to care for patients with with drug and alcohol use.

    Measured: End of intervention period, up to 21 months

  65. PCPs REDUCE-HARM instrument score

    The REDUCE-HARM instrument is a 24-item scale to measure healthcare professional attitudes to work with people who inject drugs including self-reported skills in different aspects of substance use as well as attitudes towards individuals who use drugs. Each item is ranked from 1 = not at all important to 3 = very important. Higher scores indicate positive attitudes toward caring for patients with SUD.

    Measured: Baseline

  66. PCPs REDUCE-HARM instrument score

    The REDUCE-HARM instrument is a 24-item scale to measure healthcare professional attitudes to work with people who inject drugs including self-reported skills in different aspects of substance use as well as attitudes towards individuals who use drugs. Each item is ranked from 1 = not at all important to 3 = very important. Higher scores indicate positive attitudes toward caring for patients with SUD.

    Measured: End of intervention period, up to 21 months

  67. PCPs Addictions Knowledge Questions score

    The Addictions Knowledge Questions is a 6-question measure that asks basic knowledge questions about DSM-criteria for SUD, and pharmacological treatments for OUD and AUD. Each item is answered by the PCP with a choice of "Correct" or "Incorrect". The score is calculated by the adding the number of items that are answered with "Correct". Total scores range from 0-6, a higher score indicating better knowledge.

    Measured: Baseline

  68. PCPs Addictions Knowledge Questions score

    The Addictions Knowledge Questions is a 6-question measure that asks basic knowledge questions about DSM-criteria for SUD, and pharmacological treatments for OUD and AUD. Each item is answered by the PCP with a choice of "Correct" or "Incorrect". The score is calculated by the adding the number of items that are answered with "Correct". Total scores range from 0-6, a higher score indicating better knowledge.

    Measured: End of intervention period, up to 21 months

Timeline

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

  1. First posted3 Nov 2023
  2. Study start31 Jan 2025
  3. Primary completionOct 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06116266
Sponsor's protocol ID
23-01169
Other IDs
UG1DA013035
Status last verified
May 2026
First submitted
31 Oct 2023
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm) and (for HEAL-funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy). Primary data for this study will be available to the public in the NIDA data repository. For more details on data sharing please visit https://datashare.nida.nih.gov/. The primary outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).

Questions about this trial

What is this clinical trial studying?

A study testing Education and support for primary care providers (PCPS), Nurse Care Manager (NCM) visits and Addiction specialist consultant in people with Substance Use, run by NYU Langone Health at 8 sites 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Total days of use of opioids, stimulants, and alcohol heavy drinking (time frame: Month 4-6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 May 2026.

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