SBIRT for Pain Management in Substance Use Disorders

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called SBIRT-PM (Screening, Brief Intervention, and Referral to Treatment for Pain Management) to help veterans manage chronic pain and reduce risky substance use. The treatment involves phone counseling to encourage veterans to explore various non-drug pain management options and decrease reliance on substances. Veterans who have applied for compensation for musculoskeletal (MSD) issues and experience moderate to severe pain might be a good fit. As an unphased trial, this study provides veterans with a unique opportunity to explore innovative pain management strategies tailored to their needs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that SBIRT-PM is safe for pain management in substance use disorders?

Research shows that SBIRT-PM helps Veterans manage pain and reduce risky substance use. Early studies have found that this method can improve pain management without drugs. SBIRT-PM involves counseling to help Veterans find non-drug ways to manage pain, making it a low-risk option.

The treatment includes discussions with a clinician about non-drug methods for handling pain. This approach is generally safe and well-tolerated because it doesn't involve new medications. Reports of significant side effects are absent since it mainly involves discussions and planning for better pain care.

In summary, SBIRT-PM is a safe choice for managing pain while reducing substance use. It uses counseling to support Veterans, so there are few risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SBIRT-PM because it offers a fresh approach to managing chronic pain in veterans with substance use disorders. Unlike standard treatments that often rely heavily on medications, SBIRT-PM emphasizes non-pharmacological pain management strategies, encouraging veterans to explore a range of therapies beyond just pills. This approach not only addresses the pain directly but also helps manage substance misuse by motivating veterans to consider healthier pain management options. This dual focus on pain and substance use makes SBIRT-PM a promising method that could lead to better overall outcomes for veterans struggling with these intertwined issues.

What evidence suggests that SBIRT-PM is effective for pain management in substance use disorders?

Research has shown that SBIRT-PM, the experimental treatment in this trial, can help veterans manage pain and reduce substance misuse. SBIRT-PM guides veterans to use various methods for pain treatment while addressing their substance use. Studies indicate that veterans participating in SBIRT-PM are more likely to adopt comprehensive pain management strategies. SBIRT-PM also helps veterans understand how substances impact their pain and encourages healthier behavior changes. This approach has shown promise in improving pain management and reducing risky substance use. ^{1 2 3 4 6}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7734657/

Screening, Brief Intervention, and Referral to Treatment for ... SBIRT-PM could help Veterans, at the time of their compensation claims, use multimodal pain treatments and reduce existing substance misuse.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33313731/

SBIRT-PM Study Protocol - PubMed A multisite randomized clinical trial is testing the effectiveness and cost-effectiveness of Screening, Brief Intervention, and Referral to Treatment for Pain ...

3. academic.oup.com academic.oup.com/painmedicine/article/25/Supplement_1/S99/7887771

Screening, brief intervention, and referral to treatment for pain ... The proportion of participants who receive any SBIRT-PM will be the primary implementation outcome. Veteran participants will complete baseline, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04062214

Study Details | NCT04062214 | Pragmatic RCT of SBIRT-PM The Investigators propose to test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management ( ...

5. journals.lww.com journals.lww.com/c-orthopaedicpractice/fulltext/2022/03000/screening,_brief_intervention,_and_referral_to.3.aspx

Screening, brief intervention, and referral to treatment... Patients who screened as medium or high risk were 5.8 and 8.4 times more likely, respectively, to receive intervention compared with patients who screened to ...

6. samhsa.gov samhsa.gov/substance-use/treatment/sbirt

Screening, Brief Intervention, and Referral to Treatment ... The percentage of clients who reported they had not used alcohol or illegal drugs within the past 30 days increased by 128.8% between initial ...