Pragmatic RCT of SBIRT-PM

NCT04062214 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1101

Last updated 2026-03-03

Study results available
· View outcomes & findings →

Summary

Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. The Investigators propose to test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM), designed to reduce pain and reduce risky substance use, in part by helping Veterans get comprehensive pain treatment. The study will involve clinicians at a single site contacting Veterans throughout New England by phone to deliver SBIRT-PM counseling in a pragmatic, randomized, clinical trial.

Conditions

Interventions

BEHAVIORAL

SBIRT-PM

SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • US Department of Veterans Affairs

    collaborator FED
  • Yale University

    lead OTHER

Principal Investigators

  • Marc Rosen, MD · Yale University/ VA Connecticut Healthcare System

  • Steve Martino, PhD · Yale University/ VA Connecticut Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-23
Primary Completion
2024-04-11
Completion
2024-04-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062214 on ClinicalTrials.gov