SBIRT for Pain Management in Substance Use Disorders

Recruiting at 8 trial locations

Overseen By Christina Lazar, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Inability to participate, Non-pharmacological treatments, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 36 weeks

1101 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Marc Rosen, MD

Principal Investigator

Yale University/ VA Connecticut Healthcare System

Steve Martino, PhD

Principal Investigator

Yale University/ VA Connecticut Healthcare System

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SBIRT-PM counseling to address pain management and substance use

36 weeks

Phone contacts throughout the trial

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 weeks

Outcome assessment by phone at 12 and 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SBIRT-PM

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.

How Is the Trial Designed?

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+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+