NCT06116266

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-01-31
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2023-11-03
• Last updated: 2026-02-06

Locations

8 sites across 1 country: United States