Clinical trial NCT06116266: Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)
Official title: NIDA CTN Protocol 0139: Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-11-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Total days of use of opioids, stimulants, and alcohol heavy drinking
timeFrame: Month 4-6
Secondary outcomes:
measure: Treatment Effectiveness Assessment (TEA) total score
timeFrame: Baseline
measure: Treatment Effectiveness Assessment (TEA) total score
timeFrame: Month 3
measure: Treatment Effectiveness Assessment (TEA) total score
timeFrame: Month 6
measure: Treatment Effectiveness Assessment (TEA) total score
timeFrame: Month 12
measure: Total days of use of opioids, stimulants, and alcohol
timeFrame: Months 10-12
measure: Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol
timeFrame: Month 6
measure: Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol
timeFrame: Month 12
measure: Number of days of nonmedical benzodiazepine use
timeFrame: Baseline
measure: Number of days of nonmedical benzodiazepine use
timeFrame: Months 4-6
measure: Number of days of nonmedical benzodiazepine use
timeFrame: Months 10-12
measure: Proportion of patients with receipt of a prescription for a medication used for SUD treatment
timeFrame: Baseline
measure: Proportion of patients with receipt of a prescription for a medication used for SUD treatment
timeFrame: Month 3
measure: Proportion of patients with receipt of a prescription for a medication used for SUD treatment
timeFrame: Month 6
measure: Proportion of patients with receipt of a prescription for a medication used for SUD treatment
timeFrame: Month 12
measure: Proportion of patients attending behavioral health visit(s) addressing substance use
timeFrame: Baseline
measure: Proportion of patients attending behavioral health visit(s) addressing substance use
timeFrame: Month 3
measure: Proportion of patients attending behavioral health visit(s) addressing substance use
timeFrame: Month 6
measure: Proportion of patients attending behavioral health visit(s) addressing substance use
timeFrame: Month 12
measure: OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
timeFrame: Baseline
measure: OUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
timeFrame: Month 6
measure: StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
timeFrame: Baseline
measure: StUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
timeFrame: Month 6
measure: AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
timeFrame: Baseline
measure: AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
timeFrame: Month 6
measure: Overdose Risk Behavior Questionnaire score
timeFrame: Baseline
measure: Overdose Risk Behavior Questionnaire score
timeFrame: Month 6
measure: Overdose Risk Behavior Questionnaire score
timeFrame: Month 12
measure: Number of episodes of a non-fatal overdose
timeFrame: Baseline
measure: Number of episodes of a non-fatal overdose
timeFrame: Month 6
measure: Number of episodes of a non-fatal overdose
timeFrame: Month 12
measure: World Health Organization Quality of Life (WHOQOL-BREF) score
timeFrame: Baseline
measure: World Health Organization Quality of Life (WHOQOL-BREF) score
timeFrame: Month 3
measure: World Health Organization Quality of Life (WHOQOL-BREF) score
timeFrame: Month 6
measure: World Health Organization Quality of Life (WHOQOL-BREF) score
timeFrame: Month 12
measure: Single-item general health question (HRQOL-1) score
timeFrame: Baseline
measure: Single-item general health question (HRQOL-1) score
timeFrame: Month 3
measure: Single-item general health question (HRQOL-1) score
timeFrame: Month 6
measure: Single-item general health question (HRQOL-1) score
timeFrame: Month 12
measure: Patient Health Questionnaire (PHQ-8) score
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-8) score
timeFrame: Month 3
measure: Patient Health Questionnaire (PHQ-8) score
timeFrame: Month 6
measure: Patient Health Questionnaire (PHQ-8) score
timeFrame: Month 12
measure: Percentage of participants with a negative suicidality screen
timeFrame: Baseline
measure: Percentage of participants with a negative suicidality screen
timeFrame: Month 3
measure: Percentage of participants with a negative suicidality screen
timeFrame: Month 6
measure: Percentage of participants with a negative suicidality screen
timeFrame: Month 12
measure: Generalized Anxiety Disorder (GAD-7) score
timeFrame: Baseline
measure: Generalized Anxiety Disorder (GAD-7) score
timeFrame: Month 3
measure: Generalized Anxiety Disorder (GAD-7) score
timeFrame: Month 6
measure: Generalized Anxiety Disorder (GAD-7) score
timeFrame: Month 12
measure: Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score
timeFrame: Baseline
measure: Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score
timeFrame: Month 3
measure: Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score
timeFrame: Month 6
measure: Primary Care Post-Traumatic Disorder Screen for DSM-5 (PC-PTSD-5) score
timeFrame: Month 12
measure: Number of Patient Reported ED visits
timeFrame: Baseline
measure: Number of Patient Reported ED visits
timeFrame: Month 6
measure: Number of Patient Reported ED visits
timeFrame: Month 12
measure: Number of patient reported hospital admissions
timeFrame: Baseline
measure: Number of patient reported hospital admissions
timeFrame: Month 6
measure: Number of patient reported hospital admissions
timeFrame: Month 12
measure: Proportion of patients with a diagnosis of OUD receiving any medication for OUD treatment
timeFrame: Month 12
measure: Proportion of patients with a diagnosis of AUD receiving any medication for AUD treatment
timeFrame: Month 12
measure: PCPs Medical Condition Regard Scale (MCRS) score
timeFrame: Baseline
measure: PCPs Medical Condition Regard Scale (MCRS) score
timeFrame: End of intervention period, up to 21 months
measure: PCPs REDUCE-HARM instrument score
timeFrame: Baseline
measure: PCPs REDUCE-HARM instrument score
timeFrame: End of intervention period, up to 21 months
measure: PCPs Addictions Knowledge Questions score
timeFrame: Baseline
measure: PCPs Addictions Knowledge Questions score
timeFrame: End of intervention period, up to 21 months
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: The Institute for Family Health
state: New York
city: Enterprise
country: United States
facility: Winding Waters Medical Clinic
state: Oregon
city: Lancaster
country: United States
facility: Union Community Care
state: Pennsylvania
city: Houston
country: United States
facility: Harris Health
state: Texas
city: Bellingham
country: United States
facility: Sea Mar Community Health Centers
state: Washington
city: Madison
country: United States
facility: Wisconsin Research & Education Network
state: Wisconsin
Study officials:
affiliation: NYU Langone Health
name: Jennifer McNeely, MD
role: PRINCIPAL_INVESTIGATOR
References: