Substance Use DisordersNCT04062214

Pragmatic RCT of SBIRT-PM

A study testing SBIRT-PM in people with Substance Use Disorders and Pain, run by Yale University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Substance Use Disorders, Pain
What is being tested?: SBIRT-PM
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,101 participants
Where: 9 sitesUnited States
Study dates: 23 Oct 2019to 11 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Reports inability to participate during the study enrollment call
Received three or more non-pharmacological pain treatment modalities within the last 12 weeks from VA.
Participating in another PMC3 study as evidenced by a research protocol alert for that study at the time the study invitation letter is mailed.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

VA Maine Healthcare System
Augusta, Maine, 04330
Edith Nourse Rogers Memorial VA Hospital (VA Bedford)
Bedford, Massachusetts, 01730
VA Boston Healthcare System
Boston, Massachusetts, 02301
VA Central Western Massachusetts Healthcare System
Leeds, Massachusetts, 02053
Manchester VA Medical Center
Manchester, New Hampshire, 03104
Yale University
New Haven, Connecticut, 06520
Providence VA Medical Center
Providence, Rhode Island, 02908
VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut, 06516
White River Junction VA Hospital
White River Junction, Vermont, 05001

Other trials in United States

About this study

Official title: Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (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.

Read the detailed description

In 2015 alone, 97,223 new Veterans under age 35 began receiving compensation for injuries related to their military service. In total, there are 559,999 post-9/11 Veterans being compensated for back or neck conditions, and a partially overlapping 596,250 for limitation of flexion in joints. Veterans seeking compensation for musculoskeletal conditions often develop chronic pain and are at high risk for substance misuse. Early intervention is needed to arrest worsening pain and risky substance use, particularly among post-9/11 Veterans for whom engagement in non-pharmacological pain treatment has the potential to improve their overall quality of life and spare them the complications of opioid treatments. The service-connection application is an ideal point-of contact for initiating early intervention treatments for these at-risk Veterans. 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 risky substance use. In brief, the counselor explains that treating both physical and psychological aspects of pain leads to the best outcomes, outlines what VA (and non-VA if preferred) services are available to Veterans, explains that substances are sometimes used for pain relief, and segues into traditional SBIRT. SBIRT-PM's efficacy is supported by a completed clinical trial of 101 Veterans applying for service-connection for MSD, and by studies showing the efficacy of SBIRT for people with risky substance use and of Motivational Interviewing for engagement in non-pharmacological pain care.

During a two-years pilot study, the study team prepared SBIRT-PM for implementation by establishing communication (Relational Coordination is the theoretical framework) between the "hub" where the SBIRT-PM clinician is sited and the "spoke" sites, establishing study related procedures, and piloting the intervention at each of the eight VA medical centers in New England.

In this full clinical trial, investigators will randomize 1100 Veterans applying for compensation related to MSD to either SBIRT-PM or Usual Care (UC) across eight VA medical centers in New England. Outcome assessment by phone will occur at 12 and 36-week follow-ups, and will be corroborated with other sources of information ---the electronic health record. Investigators hypothesize that, compared to Usual Care, SBIRT-PM will be more effective and cost-effective in improving Veterans' pain and substance use. Investigators further hypothesize that a mediator of these improvements will be use of non-pharmacological services, as extracted from VA records from structured data fields and from narrative text in the medical record using an innovative natural language processing algorithm. Screening and referral to treatment at service-connection examinations can transform a widely-used point of entry to VA into a health promoting encounter.

Conditions: Substance Use Disorders, Pain
Being tested: SBIRT-PM
Medical subject headings: Substance-Related Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SBIRT-PMBehavioural
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.

Study groups in NCT04062214
Study group	Role	What they receive
SBIRT-PM	Experimental	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. Receives: Behavioral: SBIRT-PM
Usual Care	No 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Intensity Subscale of Brief Pain Inventory
Pain Intensity subscale of the Brief Pain Inventory uses a 0-10 numeric rating scale (0=no pain to 10=pain as bad as you can imagine) to measure four pain severity/intensity items: "worst" pain in the last 24 hours, "least" pain in the last 24 hours, "average" pain, and pain right "now". The pain intensity subscale is scored as a composite of the four pain items (mean intensity score).
Measured: 36 weeks
Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed to detect and manage substance use and related problems. Substance use will be measured over the last 3 months using Version 3.1.After a screening question focusing on substances ever used, the ASSIST consists of 7 questions about use of and consequences of use of each of 11 classes of substances over the preceding three months (including nicotine, THC and medical THC). Scores are generated for each substance that are mapped to a three-point ordinal score of severity: "no need for treatment", "need for a brief intervention" and "need for an intensive intervention". The number of problem substances are defined as the number of substances above the "no intervention" threshold
*only participants who had a problem substance reported at baseline were analyzed for this outcome
Measured: 36 weeks

Secondary outcomes (6)

Cost-Effectiveness Ratios (ICERs)
The Incremental Cost-Effectiveness Ratio (ICER) was determined as the ratio of the difference in cost (mean cost in the treatment group less mean cost in the usual care group) divided by the difference in outcomes (QALYs in the treatment group less QALYs in the usual care group) Health care system perspective costs includes the intervention and services sponsored by VA. We limited these to care for musculoskeletal disorders. The societal perspective adds the cost of health services received outside of VA and costs incurred by participants, including the value of time spent seeking health services and obtaining self-directed care, and the value of the effect of disability on employment and normal activities.
Measured: 36 weeks
Cost-Effectiveness Acceptability Curves (CEACs)
Probability that SBIRT is cost-effective compared to usual care over a range of monetary values that a decision-maker might consider the maximum acceptable to avoid to improve pain
Measured: 36 weeks
Non-pharmacological Pain Service Utilization
Number of modalities of non-opioid pain services used will be assessed using a modified version of the Pain Management Collaboratory's "non-pharmacological and self-care approaches" questionnaire. This questionnaire asks about use of a list of 3 pharmacological and 23 non-pharmacological pain treatment modalities. For each modality, respondents indicate if the treatment was used in the past three months, if the treatment was delivered in an individual or group setting or if done on own (self-care), and the number of sessions/visits attended in the past 3 months. Number of non-pharmacological modalities will be summed.
Measured: 36 weeks
Pain Interference Subscale of Brief Pain Inventory
Pain interference subscale of Brief Pain Inventory uses a 0-10 numeric rating scale (0=no interference to 10=interferes completely) to measure seven daily activities: general activity, walking, work, mood, enjoyment of life, relations with others, sleep. The pain interference subscale is scored as the mean of the seven interference items. This mean can be used if more than 50% (4/7 items) have been completed on a given administration.
Measured: 36 weeks
Overall Health Measured by EQ-5D-5L
The Eq-5D-5L is a standardized measure of health status designed for clinical and economic appraisals. It includes a health scale which asks respondents to rate their health today on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: 36 weeks
Individual Substances of Misuse Generated by the ASSIST
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (Version 3.1) measures substance use risk over the last 3 months. It consists of 7 questions about use of and consequences of use for 11 classes of substances (including nicotine, THC and medical THC).
Scores for each substance are summed and mapped to a three-point ordinal score of severity. Risk scores for alcohol range from 0-39, where a score of 0-10 indicates "no need for treatment", a score of 11-26 indicates "need for a brief intervention" and a score of 27+ indicates "need for an intensive intervention". Risk scores for tobacco range from 0-31, risk scores for all other substances range from 0-39, where a score of 0-3 indicates "no need for treatment", a score of 4-26 indicates "need for a brief intervention" and a score of 27+ indicates "need for an intensive intervention".
Individual substances rated above the "no intervention" threshold will be analyzed here.
Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 201911 Apr 2024

First posted20 Aug 2019
Study start23 Oct 2019
Primary completion11 Apr 2024
Study completion11 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Substance Use DisordersStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants receive either usual care or study intervention
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04062214
Sponsor's protocol ID: 2000022664
Other IDs: 4UH3AT009758-03, 1UG3AT009758-01
Status last verified: May 2026
First submitted: 13 Aug 2019
Last updated: 8 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Barnett PG, Gilstad-Hayden K, Lazar CM, Martino S, Rosen MI. The cost-effectiveness of motivational interviewing to activate pain support in veterans seeking compensation for musculoskeletal conditions: multisite randomised clinical trial. BMJ Open. 2026 Aug 28;16(8):e119224. doi: 10.1136/bmjopen-2026-119224.
PubMed 42665354
Rosen MI, Gilstad-Hayden K, Lazar CM, Sellinger J, Mattocks K, Barnett PG, Brummett BR, Higgins DM, Holtzheimer P, Livingston NA, Ngo T, Reznik TE, Schimelman B, Semiatin AM, Solzhenitsyn C, Martino S. Motivational Interviewing Targeting Pain and Substance Use in Veterans Seeking Service-Connection Payments: A Multisite Randomized Clinical Trial. J Gen Intern Med. 2026 Feb 25. doi: 10.1007/s11606-025-10127-2. Online ahead of print.
PubMed 41741869

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (TRIAL)
ClinicalTrials.gov ID: NCT04062214
Acronym / sponsor ID: 2000022664
Conditions: Substance Use Disorders, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,101 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH), National Institute on Drug Abuse (NIDA), US Department of Veterans Affairs
Study start: 23 Oct 2019 (actual)
Primary completion: 11 Apr 2024 (actual)
Study completion: 11 Apr 2024 (actual)
First posted: 20 Aug 2019 (actual)
Results: Posted 7 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Participants receive either usual care or study intervention

Arm	Type	Receives
SBIRT-PM	Experimental	Behavioral: SBIRT-PMScreening, 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.
Usual Care	No 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 may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

Reports inability to participate during the study enrollment call
Received three or more non-pharmacological pain treatment modalities within the last 12 weeks from VA.
Participating in another PMC3 study as evidenced by a research protocol alert for that study at the time the study invitation letter is mailed.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SBIRT-PMSBIRT-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.	Behavioural	SBIRT-PM

Primary outcome

Change in Pain Intensity Subscale of Brief Pain Inventory
Time frame: 36 weeks
Pain Intensity subscale of the Brief Pain Inventory uses a 0-10 numeric rating scale (0=no pain to 10=pain as bad as you can imagine) to measure four pain severity/intensity items: "worst" pain in the last 24 hours, "least" pain in the last 24 hours, "average" pain, and pain right "now". The pain intensity subscale is scored as a composite of the four pain items (mean intensity score).
Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: 36 weeks
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed to detect and manage substance use and related problems. Substance use will be measured over the last 3 months using Version 3.1.After a screening question focusing on substances ever used, the ASSIST consists of 7 questions about use of and consequences of use of each of 11 classes of substances over the preceding three months (including nicotine, THC and medical THC). Scores are generated for each substance that are mapped to a three-point ordinal score of severity: "no need for treatment", "need for a brief intervention" and "need for an intensive intervention". The number of problem substances are defined as the number of substances above the "no intervention" threshold *only participants who had a problem substance reported at baseline were analyzed for this outcome

6 secondary outcomes

Cost-Effectiveness Ratios (ICERs)
Time frame: 36 weeks
Cost-Effectiveness Acceptability Curves (CEACs)
Time frame: 36 weeks
Non-pharmacological Pain Service Utilization
Time frame: 36 weeks
Pain Interference Subscale of Brief Pain Inventory
Time frame: 36 weeks
Overall Health Measured by EQ-5D-5L
Time frame: 36 weeks
Individual Substances of Misuse Generated by the ASSIST
Time frame: 36 weeks

Results and safety

Results posted to the registry on 7 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SBIRT-PM	558	457
Usual Care	543	432

Primary outcome: Change in Pain Intensity Subscale of Brief Pain Inventory

Time frame: 36 weeks. Mean (95% Confidence Interval). Unit: score on a scale

Measure	SBIRT-PM n = 558	Usual Care n = 543
week 0	5.39 (5.28 to 5.49)	5.39 (5.28 to 5.50)
week 12	5.02 (4.88 to 5.15)	4.97 (4.81 to 5.14)
week 36	4.60 (4.45 to 4.76)	4.86 (4.69 to 5.02)

Primary outcome: Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

Time frame: 36 weeks. Mean (95% Confidence Interval). Unit: # substances that need treatment

Measure	SBIRT-PM n = 277	Usual Care n = 295
week 0	1.47 (1.38 to 1.56)	1.47 (1.38 to 1.57)
week 12	1.32 (1.20 to 1.44)	1.19 (1.07 to 1.32)
week 36	1.26 (1.12 to 1.39)	1.19 (1.06 to 1.31)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SBIRT-PM	100 of 558 (17.9%)	109 of 558 (19.5%)	1 of 558
Usual Care	92 of 543 (16.9%)	89 of 543 (16.4%)	2 of 543

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42665354Barnett PG, Gilstad-Hayden K, Lazar CM, Martino S, Rosen MI. The cost-effectiveness of motivational interviewing to activate pain support in veterans seeking compensation for musculoskeletal conditions: multisite randomised clinical trial. BMJ Open. 2026 Aug 28;16(8):e119224. doi: 10.1136/bmjopen-2026-119224.
Derived from this study: PubMed 41741869Rosen MI, Gilstad-Hayden K, Lazar CM, Sellinger J, Mattocks K, Barnett PG, Brummett BR, Higgins DM, Holtzheimer P, Livingston NA, Ngo T, Reznik TE, Schimelman B, Semiatin AM, Solzhenitsyn C, Martino S. Motivational Interviewing Targeting Pain and Substance Use in Veterans Seeking Service-Connection Payments: A Multisite Randomized Clinical Trial. J Gen Intern Med. 2026 Feb 25. doi: 10.1007/s11606-025-10127-2. Online ahead of print.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc Rosen, MD principal investigator

Yale University/ VA Connecticut Healthcare System

Steve Martino, PhD principal investigator

Yale University/ VA Connecticut Healthcare System

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SBIRT-PM in people with Substance Use Disorders and Pain, run by Yale University at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Intensity Subscale of Brief Pain Inventory (time frame: 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04062214, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.