Substance Use DisordersNCT03307967

Pilot of Pragmatic SBIRT Study

A study testing SBIRT-PM in people with Substance Use Disorders and Pain, run by Yale University at 2 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: 40 participants
Where: 2 sitesUnited States
Study dates: 15 Jan 2019to 17 Jun 2019
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 pain ≥4 on the pain Numerical Rating Scale (threshold for moderately severe pain);
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 (as previously categorized within the last 12 weeks from VA.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Yale University
New Haven, Connecticut, 06520
VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut, 06516

Other trials in United States

About this study

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

Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention.

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.

This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention.

During the two-years pilot trial, the team will prepare 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.

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 NCT03307967
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

What is being measured

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

Non-Pharm Pain Treatment Modalities Received
A self-reported measure developed by the Pain Management Collaboaratory (PMC3). Questionnaire asks about the use of 13 different non-pharmacological pain treatments over the past 3 months. Below we present the mean number of non-pharmacological pain treatments received at baseline and then at week 12.
Measured: Baseline, Week 12
Substance Use
Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). This self-reported assessment asks about the use of 10 classes of substances used over the preceding 3 months. In the below table, we present the number of participants that endorsed having used the indicated substance at baseline and week 12.
Measured: Baseline, week 12
Change in Pain Severity
Measured by the pain severity subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain severity subscale consists of 4 items (worst pain, least pain, average pain, current pain) rated in the past 24 hours on a 0-10 scale- higher scores indicate higher pain severity. The four items are averaged to get a score. Below we present the mean, within-person change in pain severity from baseline to week 12. Minimally clinically important difference would be a 30% reduction in pain severity.
Measured: Baseline to 12 weeks
Change in Pain Interference
Measured by the pain interference subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain interference subscale consists of 7 items rated in the past 24 hours on a 0-10 scale- higher scores indicate higher interference from pain. The 7 items are averaged to get a score. Below we present the mean, within-person change in pain intensity from baseline to week 12. Minimally clinically important difference would be a 1 point reduction in pain intensity.
Measured: Baseline to 12 weeks

Timeline

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

15 Jan 201917 Jun 2019

First posted12 Oct 2017
Study start15 Jan 2019
Primary completion17 Jun 2019
Study completion17 Jun 2019

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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03307967
Sponsor's protocol ID: 2000022664_a
Other IDs: UG3AT009758
Status last verified: Feb 2024
First submitted: 5 Oct 2017
Last updated: 15 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sellinger JJ, Martino S, Lazar C, Mattocks K, Rando K, Serowik K, Ablondi K, Fenton B, Gilstad-Hayden K, Brummett B, Holtzheimer PE, Higgins D, Reznik TE, Semiatin AM, Stapley T, Ngo T, Rosen MI. The acceptability and feasibility of screening, brief intervention, and referral to treatment for pain management among new England veterans with chronic pain: A pilot study. Pain Pract. 2022 Jan;22(1):28-38. doi: 10.1111/papr.13023. Epub 2021 Jun 26.
PubMed 33934499
Rosen MI, Martino S, Sellinger J, Lazar CM, Fenton BT, Mattocks K. Access to Pain Care From Compensation Clinics: A Relational Coordination Perspective. Fed Pract. 2020 Jul;37(7):336-342.
PubMed 32908339

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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (PILOT)
ClinicalTrials.gov ID: NCT03307967
Acronym / sponsor ID: 2000022664_a
Conditions: Substance Use Disorders, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 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: 15 Jan 2019 (actual)
Primary completion: 17 Jun 2019 (actual)
Study completion: 17 Jun 2019 (actual)
First posted: 12 Oct 2017 (actual)
Results: Posted 16 May 2022

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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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.

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 pain ≥4 on the pain Numerical Rating Scale (threshold for moderately severe pain);
Availability of a landline or cellular telephone for SBIRT-PM.

Key exclusion criteria (2 listed)

Reports inability to participate during the study enrollment call
Received three or more non-pharmacological pain treatment modalities (as previously categorized within the last 12 weeks from VA.

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

Non-Pharm Pain Treatment Modalities Received
Time frame: Baseline, Week 12
A self-reported measure developed by the Pain Management Collaboaratory (PMC3). Questionnaire asks about the use of 13 different non-pharmacological pain treatments over the past 3 months. Below we present the mean number of non-pharmacological pain treatments received at baseline and then at week 12.
Substance Use
Time frame: Baseline, week 12
Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). This self-reported assessment asks about the use of 10 classes of substances used over the preceding 3 months. In the below table, we present the number of participants that endorsed having used the indicated substance at baseline and week 12.
Change in Pain Severity
Time frame: Baseline to 12 weeks
Measured by the pain severity subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain severity subscale consists of 4 items (worst pain, least pain, average pain, current pain) rated in the past 24 hours on a 0-10 scale- higher scores indicate higher pain severity. The four items are averaged to get a score. Below we present the mean, within-person change in pain severity from baseline to week 12. Minimally clinically important difference would be a 30% reduction in pain severity.
Change in Pain Interference
Time frame: Baseline to 12 weeks
Measured by the pain interference subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain interference subscale consists of 7 items rated in the past 24 hours on a 0-10 scale- higher scores indicate higher interference from pain. The 7 items are averaged to get a score. Below we present the mean, within-person change in pain intensity from baseline to week 12. Minimally clinically important difference would be a 1 point reduction in pain intensity.

Results and safety

Results posted to the registry on 16 May 2022, 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	40	36

Primary outcome: Non-Pharm Pain Treatment Modalities Received

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: non-pharm pain treatments

Measure	SBIRT-PM n = 36
# non-pharm pain treatments at Baseline	.93 (1.0)
# non-pharm pain treatments at week 12	1.3 (1.3)

Primary outcome: Substance Use

Time frame: Baseline, week 12. Number. Unit: participants

Measure	SBIRT-PM n = 36
Baseline : Alcohol	13
Baseline : Nicotine	16
Baseline : Other Drugs	7
Baseline : Alcohol or drugs	27
Week 12 : Alcohol	6
Week 12 : Nicotine	15
Week 12 : Other Drugs	8
Week 12 : Alcohol or drugs	22

Primary outcome: Change in Pain Severity

Time frame: Baseline to 12 weeks. Mean (Standard Deviation). Unit: within-person change in score on a scale

Measure	SBIRT-PM n = 36
Value	-.41 (1.3)

SBIRT-PM: p = .07, Wilcoxon (Mann-Whitney)

Primary outcome: Change in Pain Interference

Time frame: Baseline to 12 weeks. Mean (Standard Deviation). Unit: within-person change on a scale

Measure	SBIRT-PM n = 36
Value	.08 (1.6)

SBIRT-PM: p = .98, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SBIRT-PM	0 of 40 (0%)	8 of 40 (20%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33934499Sellinger JJ, Martino S, Lazar C, Mattocks K, Rando K, Serowik K, Ablondi K, Fenton B, Gilstad-Hayden K, Brummett B, Holtzheimer PE, Higgins D, Reznik TE, Semiatin AM, Stapley T, Ngo T, Rosen MI. The acceptability and feasibility of screening, brief intervention, and referral to treatment for pain management among new England veterans with chronic pain: A pilot study. Pain Pract. 2022 Jan;22(1):28-38. doi: 10.1111/papr.13023. Epub 2021 Jun 26.
Results publication: PubMed 32908339Rosen MI, Martino S, Sellinger J, Lazar CM, Fenton BT, Mattocks K. Access to Pain Care From Compensation Clinics: A Relational Coordination Perspective. Fed Pract. 2020 Jul;37(7):336-342.
Individual participant dataSharing planned: No

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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

2 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 2 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 2 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 16 May 2022). 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?

Non-Pharm Pain Treatment Modalities Received (time frame: Baseline, Week 12). The study lists 4 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 NCT03307967, 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 15 Feb 2024.