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.
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
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 group | Role | What they receive |
|---|---|---|
| Co-Care | Experimental | Patient 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 comparator | Patient 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of episodes of a non-fatal overdose
Outcome measure is self reported on the Non-Fatal Overdose Questionnaire.
Measured: Baseline
Number of episodes of a non-fatal overdose
Outcome measure is self reported on the Non-Fatal Overdose Questionnaire.
Measured: Month 6
Number of episodes of a non-fatal overdose
Outcome measure is self reported on the Non-Fatal Overdose Questionnaire.
Measured: Month 12
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Number of Patient Reported ED visits
Measured: Baseline
Number of Patient Reported ED visits
Measured: Month 6
Number of Patient Reported ED visits
Measured: Month 12
Number of patient reported hospital admissions
Measured: Baseline
Number of patient reported hospital admissions
Measured: Month 6
Number of patient reported hospital admissions
Measured: Month 12
Proportion of patients with a diagnosis of OUD receiving any medication for OUD treatment
Measured: Month 12
Proportion of patients with a diagnosis of AUD receiving any medication for AUD treatment
Measured: Month 12
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
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
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
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
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
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.
- First posted3 Nov 2023
- Study start31 Jan 2025
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jennifer McNeely, MD, Principal investigator, NYU Langone Health
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/).
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIDA CTN Protocol 0139: Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)
- ClinicalTrials.gov ID
- NCT06116266
- Acronym / sponsor ID
- 23-01169
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 301 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-Care | Experimental | Other: Education and support for primary care providers (PCPS), Other: Nurse Care Manager (NCM) visits, Other: Addiction specialist consultant, Other: Health coaching sessionsPatient 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. |
| Enhanced Usual Care (EUC) | Active comparator | Other: Education and support for primary care providers (PCPS), Other: Patient educational materialsPatient participants with providers will receive primary care treatment as usual plus educational materials. |
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 |
|---|---|---|
| Education and support for primary care providers (PCPS)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. | Other | Co-Care, Enhanced Usual Care (EUC) |
| Nurse Care Manager (NCM) visitsA 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 | Other | Co-Care |
| Addiction specialist consultantAn addiction specialist consultant who supports the nurse care manager and PCP in formulating and adjusting treatment plans | Other | Co-Care |
| Health coaching sessionsHealth 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. | Other | Co-Care |
| Patient educational materialsPatient participants receive an educational pamphlet addressing overdose prevention, information about accessing naloxone, and local SUD treatment options. | Other | Enhanced Usual Care (EUC) |
Primary outcome
Total days of use of opioids, stimulants, and alcohol heavy drinking
Time frame: Month 4-6
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.
68 secondary outcomes
Treatment Effectiveness Assessment (TEA) total score
Time frame: Baseline
Treatment Effectiveness Assessment (TEA) total score
Time frame: Month 3
Treatment Effectiveness Assessment (TEA) total score
Time frame: Month 6
Treatment Effectiveness Assessment (TEA) total score
Time frame: Month 12
Total days of use of opioids, stimulants, and alcohol
Time frame: Months 10-12
Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol
Time frame: Month 6
Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol
Time frame: Month 12
Number of days of nonmedical benzodiazepine use
Time frame: Baseline
Number of days of nonmedical benzodiazepine use
Time frame: Months 4-6
Number of days of nonmedical benzodiazepine use
Time frame: Months 10-12
Proportion of patients with receipt of a prescription for a medication used for SUD treatment
Time frame: Baseline
Proportion of patients with receipt of a prescription for a medication used for SUD treatment
Time frame: Month 3
Proportion of patients with receipt of a prescription for a medication used for SUD treatment
Time frame: Month 6
Proportion of patients with receipt of a prescription for a medication used for SUD treatment
Time frame: Month 12
Proportion of patients attending behavioral health visit(s) addressing substance use
Time frame: Baseline
Proportion of patients attending behavioral health visit(s) addressing substance use
Time frame: Month 3
Proportion of patients attending behavioral health visit(s) addressing substance use
Time frame: Month 6
Proportion of patients attending behavioral health visit(s) addressing substance use
Time frame: Month 12
OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
Time frame: Baseline
OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
Time frame: Month 6
StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
Time frame: Baseline
StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
Time frame: Month 6
AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
Time frame: Baseline
AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
Time frame: Month 6
Overdose Risk Behavior Questionnaire score
Time frame: Baseline
Overdose Risk Behavior Questionnaire score
Time frame: Month 6
Overdose Risk Behavior Questionnaire score
Time frame: Month 12
Number of episodes of a non-fatal overdose
Time frame: Baseline
Number of episodes of a non-fatal overdose
Time frame: Month 6
Number of episodes of a non-fatal overdose
Time frame: Month 12
World Health Organization Quality of Life (WHOQOL-BREF) score
Time frame: Baseline
World Health Organization Quality of Life (WHOQOL-BREF) score
Time frame: Month 3
World Health Organization Quality of Life (WHOQOL-BREF) score
Time frame: Month 6
World Health Organization Quality of Life (WHOQOL-BREF) score
Time frame: Month 12
Single-item general health question (HRQOL-1) score
Time frame: Baseline
Single-item general health question (HRQOL-1) score
Time frame: Month 3
Single-item general health question (HRQOL-1) score
Time frame: Month 6
Single-item general health question (HRQOL-1) score
Time frame: Month 12
Patient Health Questionnaire (PHQ-8) score
Time frame: Baseline
Patient Health Questionnaire (PHQ-8) score
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: 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/).
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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 Health
8 sites in 1 country: see every site and its status.
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.