Status:
RECRUITING
Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Substance Use
Eligibility:
All Genders
18+ years
Phase:
NA
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 se...
Eligibility Criteria
Inclusion
- PCP
- 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
- 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
- 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
Key Trial Info
Start Date :
January 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06116266
Start Date
January 31 2025
End Date
February 1 2027
Last Update
June 6 2025
Active Locations (8)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
2
NYU Langone Health
New York, New York, United States, 10016
3
The Institute for Family Health
New York, New York, United States, 10025
4
Winding Waters Medical Clinic
Enterprise, Oregon, United States, 97828