SBIRT for Pain Management in Substance Use Disorders

Recruiting at8 trial locations

Overseen by Marc Rosen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Yale University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Steve Martino, PhD

Principal Investigator

Yale University/ VA Connecticut Healthcare System

Marc Rosen, MD

Principal Investigator

Yale University/ VA Connecticut Healthcare System

Eligibility Criteria

This trial is for post-9/11 veterans who are applying for compensation due to musculoskeletal conditions, have moderate to severe pain (scoring ≥4 on a pain scale), and own a phone. It's not open to those unable or unwilling to participate, those already receiving multiple non-drug pain treatments from the VA, or participants in another related study.

Inclusion Criteria

Reports a score of ≥4 (threshold for moderately severe pain) on the BPI's Pain Severity subscale (average of four pain intensity items)

Availability of a landline or cellular telephone for SBIRT-PM

Post-9/11 Veteran applying for MSD-related compensation, as ascertained from filed claim

Exclusion Criteria

I have tried three or more non-drug pain treatments from the VA in the last 3 months.

Participating in another PMC3 study as evidenced by a research protocol alert for that study at the time the study invitation letter is mailed.

Reports inability to participate during the study enrollment call

Treatment Details

Interventions

• SBIRT-PM (Behavioral Intervention)

Trial Overview The SBIRT-PM program is being tested for its effectiveness in reducing chronic pain and risky substance use among veterans. The program involves clinicians contacting veterans by phone across New England as part of a pragmatic randomized clinical trial.

Participant Groups

Group I: SBIRT-PM Experimental Treatment 1 Intervention

Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) was developed to promote engagement in multi-modal non-pharmacological pain management among compensation-seeking Veterans with chronic pain. In SBIRT-PM, a clinician meets with the Veteran after the compensation examination to address the presenting MSD complaint. The clinician addresses Veterans' motivation for multi-modal pain care, and explains how pain can be managed using a variety of non-pharmacological pain management services. The clinician spells out how those services can be accessed at VA. Using permissive language about how pain is commonly self-medicated with substances, the clinician transitions to inquiries about use of prescription and non-prescription substances. The clinician then attempts to motivate Veterans to change their behavior if they are misusing substances. Thus, SBIRT-PM addresses the Veteran's presenting pain complaint first and nascent substance use subsequently.

Group II: Usual Care Active Control 1 Intervention

A Veteran who completes a Compensation examination ordinarily has no further treatment, referral or debriefing as part of the Compensation examination. Veterans will be advised that they should continue to pursue whatever counseling they need outside the study.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Dr. Amy P. Patterson

National Center for Complementary and Integrative Health (NCCIH)

Chief Medical Officer

MD from Johns Hopkins University

Dr. Helene Langevin

National Center for Complementary and Integrative Health (NCCIH)

Chief Executive Officer since 2018

MD from McGill University

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Kameron Leigh Matthews

US Department of Veterans Affairs

Chief Medical Officer since 2021

MD from Johns Hopkins University

Doug Collins

US Department of Veterans Affairs

Secretary of Veterans Affairs

BA in Political Science from North Georgia College & State University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico