Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Opioid Use Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This cluster randomized trial, conducted in primary care clinics and randomized at the level of the PCP, will compare the STOP intervention to enhanced usual care (EUC) for 12 months. Patients who are eligible and enroll will receive the intervention according to the assignment of their PCP. In the ...

This cluster randomized trial, conducted in primary care clinics and randomized at the level of the PCP, will compare the STOP intervention to enhanced usual care (EUC) for 12 months. Patients who are eligible and enroll will receive the intervention according to the assignment of their PCP. In the EUC arm, PCPs conduct primary care as usual, without support of the nurse care manager. Patient participants receive an educational pamphlet about overdose prevention and watch a brief video on "healthy living" that is not specific to substance use. In the STOP arm, PCPs and their enrolled patient participants receive the STOP intervention, consisting of a NCM, brief advice about health risks of opioid misuse, and telephone health coaching. Patient participants in either arm who are found by clinical providers to have developed a moderate-severe OUD at any time during the study can be offered medication for OUD and linked to treatment by clinical staff in the EUC arm, and the NCM in the STOP arm, to formal assessment and MOUD treatment.

Tracking Information

NCT #
NCT04218201
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Jennifer McNeely, MD NYU Langone