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SBIRT for Pain Management in Substance Use Disorders

N/A

Waitlist Available

Led By Steve Martino, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks

Awards & highlights

Study Summary

This trial will test whether a Screening, Brief Intervention and Referral to Treatment for pain management can help Veterans reduce pain and substance misuse.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves counseling rather than medication, typical drug side effects aren't expected. However, discussing sensitive topics like substance use and pain might cause emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of Problem Substances measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

Cost-Effectiveness Acceptability curves (CEACs)

Cost-Effectiveness Ratios (ICERs)

+1 more

Secondary outcome measures

Individual substances of misuse generated by the ASSIST, and nail clipping toxicology

Overall Health measured by EQ-5D-5L

Pain Interference subscale of Brief Pain Inventory

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SBIRT-PMExperimental Treatment1 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 CareActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SBIRT-PM

2014

N/A

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH

831 Previous Clinical Trials

667,833 Total Patients Enrolled

33 Trials studying Pain

18,680 Patients Enrolled for Pain

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,735,428 Total Patients Enrolled

14 Trials studying Pain

2,230 Patients Enrolled for Pain

US Department of Veterans AffairsFED

868 Previous Clinical Trials

486,790 Total Patients Enrolled

13 Trials studying Pain

1,867 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment have an age restriction, and if so, is it above or below 70?

"Patients aged 18 to 100 may be eligible for this trial and there are additional trials catering to minors (146) and seniors (498)."

Answered by AI

How many participants are enrolled in this investigation?

"Indeed, the details released on clinicaltrials.gov demonstrate that this experiment is presently recruiting participants. This research was first published in October 2019 and most recently updated in May 2022; it aims to recruit a total of 1100 individuals from 8 distinct sites."

Answered by AI

Are there any vacant slots for participants within this clinical trial?

"Affirmative. Per the information on clinicaltrials.gov, this research project is actively looking for participants with a recruitment period that started in October 2019 and was most recently updated in May 2022. In total, 1100 people from 8 different centres are needed to complete the trial."

Answered by AI

What is the goal of this experiment?

"This trial's primary endpoint, to be measured over a 36-week period, is the Cost-Effectiveness Acceptability curves (CEACs). Secondary outcomes include non-pharmacological pain service utilization which entails collecting data on modalities used in individual or group settings and self-care approaches employed by patients. Additionally, this study will assess Pain Interference subscale of Brief Pain Inventory using a 0–10 numeric rating scale; Individual substances of misuse generated by the Alcohol, Smoking and Substance Involvement Screening Test version 3.1; as well as nail clipping toxicology results for 11 classes of substance use over three months."

Answered by AI

What is the scope of participation for this trial across medical centers?

"This experiment is enrolling patients at VA Boston Healthcare System in Massachusetts, VACHS in Connecticut, and the VA Maine Health Care System in Augusta with another 8 sites scattered throughout."

Answered by AI

How do I sign up to partake in this clinical trial?

"The medical trial is currently recruiting 1,100 individuals suffering from pain between the ages of 18 and 100. Notably, applicants must be a Post-9/11 Veteran with an active MSD-related compensation claim, report a moderate to severe level of pain on the BPI's Pain Severity subscale (average of four items), and have access to either landline or cellular telephone service for SBIRT-PM procedures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pragmatic RCT of SBIRT-PM

2019. "Pragmatic RCT of SBIRT-PM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04062214.

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