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

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.

Conditions

• Substance Use

Interventions

OTHER

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

Nurse Care Manager (NCM) visits

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

OTHER

Addiction specialist consultant

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

OTHER

Health coaching sessions

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.

OTHER

Patient educational materials

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• NYU Langone Health

  lead OTHER

Principal Investigators

• Jennifer McNeely, MD · NYU Langone Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-31

Primary Completion

2026-10-31

Completion

2027-04-30

Countries

• United States

Study Locations