Chronic PainPhase 2VOICENCT03026790

Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study

A Phase 2 study testing Medication management, Non-pharmacological pain management and Buprenorphine-Naloxone in people with Chronic Pain, run by University of Minnesota at 1 site 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 21 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Medication management, Non-pharmacological pain management and Buprenorphine-Naloxone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 820 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2017to 30 Oct 2022
Phase: Phase 2
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3 months) for chronic pain
Chronic pain of at least moderate severity (defined as pain that is present every or nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥ 5)

Who cannot join

Dementia diagnosis
Unstable or severe untreated psychiatric disorder, including severe untreated substance use disorder or active suicidal ideation
Unstable or end-stage medical disease that would interfere with participation, including cancer requiring active treatment and life expectancy < 12 months
Documentation of suspected controlled substance diversion
Inability to communicate by telephone

Trial locations and contacts

1 site in 1 country.

United States1 site

Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417

Other trials in United States

About this study

Official title: Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans

Background and significance: Treatment with opioid pain medications (like hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help and can cause serious problems. High daily doses of opioids can be especially unsafe. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to manage pain while helping patients reduce opioid medication doses to safer levels.

Read the detailed description

Study aims: This study will test which of two pain treatment strategies is better for managing pain and helping patients improve safety of opioid medication. For patients on high opioid doses who want to reduce, this study will also test whether offering an extra option for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine patients' and clinicians' experiences with the interventions.

Study description: The study will compare two treatment strategies among patients with pain who are taking long-term opioid pain medications prescribed by VA healthcare facilities across the country. Patients who wish to enter the study will be assigned by chance to telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a pharmacist and supervising physician working together to find the best medication options for each individual patient. In IPT, a team of clinicians focuses on non-medication pain management options, in addition to pain medication.

All participants will be asked to stay in the study for 12 months. Patients for whom it would be unsafe to participate will not be invited to join. With either treatment strategy, TCM or IPT, participants will have individualized pain care tailored to their needs and preferences. Participants on high opioid medication doses who want to reduce their opioid medication dose will be assigned by chance to get either a regular step-wise taper or a choice between a regular taper or switching to a different medication (buprenorphine-naloxone).

At the end of the study, the two treatment strategies will be compared to see which worked better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes important to patients will also be tracked. These include quality of life, sleep, fatigue, depression, anxiety, and side effects.

Conditions: Chronic Pain
Being tested: Medication management, Non-pharmacological pain management, Buprenorphine-Naloxone
Keywords: Opioid analgesics, Opioid partial agonists, Health care delivery, Back pain, Osteoarthritis, Veterans health
Medical subject headings: Chronic Pain, Back Pain, Osteoarthritis

What participants receive

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

Medication managementOther
Individualized management of medications for pain
Non-pharmacological pain managementOther
Individualized management of non-medication pain treatment approaches
Buprenorphine-NaloxoneDrug
Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation

Study groups in NCT03026790
Study group	Role	What they receive
Telecare collaborative management (TCM)	Active comparator	Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care. Receives: Other: Medication management
Integrated pain team (IPT)	Active comparator	Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options. Receives: Other: Medication management; Other: Non-pharmacological pain management
Standard taper options	Active comparator	The standard taper options arm uses patient education and shared decision-making to guide opioid medication management. Receives: Other: Medication management
Expanded taper options	Active comparator	The expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone. Receives: Other: Medication management; Drug: Buprenorphine-Naloxone

What is being measured

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

Pain Response
Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline
Measured: 12 months

Secondary outcomes (3)

50% Reduction in Opioid Daily Dose
Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline
Measured: 12 months
Composite Response
Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.
Measured: 12 months
Brief Pain Inventory (BPI) Total Score
Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)
Measured: 12 months

Timeline

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

19 Oct 201730 Oct 2022

First posted20 Jan 2017 (estimated)
Study start19 Oct 2017
Primary completion17 Mar 2022
Study completion30 Oct 2022

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 (4)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 820 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03026790
Sponsor's protocol ID: OPD-1511-33052
Acronym: VOICE
Status last verified: May 2023
First submitted: 1 Jan 2017
Last updated: 5 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Data sharing procedures have not been finalized. At a minimum, a complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses of the study will be created and made available within one year after the completion of the study, pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Depending on feasibility and guidance from VA Office of Research Oversight, a Limited Dataset (LDS) may be created and shared. We have not yet determined how to operationalize data sharing for this study. In the interim, contact the PI for questions or requests.

Publications

Morasco BJ, Hammett PJ, Krebs EE, Seal KH, DeRonne BM, Lovejoy TI, Bohnert ASB, Frank JW, Makris UE, Naylor JC, Painter JT, Borsari B, Hagedorn HJ, Becker WC. Pain and Opioid Dose Reduction Based on Substance Use Disorder Status: Secondary Analysis from a Pragmatic Effectiveness Trial. J Gen Intern Med. 2026 Sep 28. doi: 10.1007/s11606-026-10816-6. Online ahead of print.
PubMed 42806226
Becker WC, Seal KH, Nelson DB, DeRonne BM, Kats AM, Morasco BJ, Frank JW, Makris UE, Painter JT, Allen KD, Mixon AS, Bohnert A, Reznik TE, Hagedorn HJ, Hammett P, Borsari B, Baxley C, Krebs EE; VOICE Study Group. Buprenorphine, Pain, and Opioid Use in Patients Taking High-Dose Long-Term Opioids: A Randomized Clinical Trial. JAMA Intern Med. 2025 Apr 1;185(4):372-381. doi: 10.1001/jamainternmed.2024.8361.
PubMed 39960730
Krebs EE, Becker WC, Nelson DB, DeRonne BM, Jensen AC, Kats AM, Morasco BJ, Frank JW, Makris UE, Allen KD, Naylor JC, Mixon AS, Bohnert A, Reznik TE, Painter JT, Hudson TJ, Hagedorn HJ, Manuel JK, Borsari B, Purcell N, Hammett P, Amundson EC, Kerns RD, Barbosa MR, Garvey C, Jones EJ, Noh MY, Okere JB, Bhushan S, Pinsonnault J, Williams BE, Herbst E, Lagisetty P, Librodo S, Mapara PS, Son E, Tat C, Marraffa RA, Seys RL, Baxley C, Seal KH; VOICE Study Group. Care Models to Improve Pain and Reduce Opioids Among Patients Prescribed Long-Term Opioid Therapy: The VOICE Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):208-220. doi: 10.1001/jamainternmed.2024.6683.
PubMed 39652356
Krebs EE, Becker WC, Nelson D, DeRonne BM, Nugent S, Jensen AC, Amundson EC, Manuel JK, Borsari B, Kats AM, Seal KH. Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study. Contemp Clin Trials. 2023 Jan;124:107001. doi: 10.1016/j.cct.2022.107001. Epub 2022 Nov 13.
PubMed 36384218

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?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans
ClinicalTrials.gov ID: NCT03026790
Acronym / sponsor ID: VOICE / OPD-1511-33052
Conditions: Chronic Pain
Keywords: Opioid analgesics, Opioid partial agonists, Health care delivery, Back pain, Osteoarthritis, Veterans health
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 820 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 19 Oct 2017 (actual)
Primary completion: 17 Mar 2022 (actual)
Study completion: 30 Oct 2022 (actual)
First posted: 20 Jan 2017 (estimated)
Results: Posted 5 Jun 2023

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: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Telecare collaborative management (TCM)	Active comparator	Other: Medication managementUses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.
Integrated pain team (IPT)	Active comparator	Other: Medication management, Other: Non-pharmacological pain managementUses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Standard taper options	Active comparator	Other: Medication managementThe standard taper options arm uses patient education and shared decision-making to guide opioid medication management.
Expanded taper options	Active comparator	Other: Medication management, Drug: Buprenorphine-NaloxoneThe expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3 months) for chronic pain
Chronic pain of at least moderate severity (defined as pain that is present every or nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥ 5)

Key exclusion criteria (5 listed)

Dementia diagnosis
Unstable or severe untreated psychiatric disorder, including severe untreated substance use disorder or active suicidal ideation
Unstable or end-stage medical disease that would interfere with participation, including cancer requiring active treatment and life expectancy < 12 months
Documentation of suspected controlled substance diversion
Inability to communicate by telephone

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
Medication managementIndividualized management of medications for pain	Other	Expanded taper options, Integrated pain team (IPT), Standard taper options, Telecare collaborative management (TCM)
Non-pharmacological pain managementIndividualized management of non-medication pain treatment approaches	Other	Integrated pain team (IPT)
Buprenorphine-NaloxoneOption of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation	Drug	Expanded taper options

Primary outcome

Pain Response
Time frame: 12 months
Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline

3 secondary outcomes

50% Reduction in Opioid Daily Dose
Time frame: 12 months
Composite Response
Time frame: 12 months
Brief Pain Inventory (BPI) Total Score
Time frame: 12 months

Results and safety

Results posted to the registry on 5 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Comparator: Telecare Collaborative Management (TCM)	411	358
Active Comparator: Integrated Pain Team (IPT)	409	363

Primary outcome: Pain Response

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Active Comparator: Telecare Collaborative Management (TCM) n = 350	Active Comparator: Integrated Pain Team (IPT) n = 362
Value	58	54

3 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Active Comparator: Telecare Collaborative Management (TCM)	109 of 358 (30.4%)	207 of 358 (57.8%)	7 of 358
Active Comparator: Integrated Pain Team (IPT)	109 of 363 (30%)	178 of 363 (49%)	9 of 363

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42806226Morasco BJ, Hammett PJ, Krebs EE, Seal KH, DeRonne BM, Lovejoy TI, Bohnert ASB, Frank JW, Makris UE, Naylor JC, Painter JT, Borsari B, Hagedorn HJ, Becker WC. Pain and Opioid Dose Reduction Based on Substance Use Disorder Status: Secondary Analysis from a Pragmatic Effectiveness Trial. J Gen Intern Med. 2026 Sep 28. doi: 10.1007/s11606-026-10816-6. Online ahead of print.
Derived from this study: PubMed 39960730Becker WC, Seal KH, Nelson DB, DeRonne BM, Kats AM, Morasco BJ, Frank JW, Makris UE, Painter JT, Allen KD, Mixon AS, Bohnert A, Reznik TE, Hagedorn HJ, Hammett P, Borsari B, Baxley C, Krebs EE; VOICE Study Group. Buprenorphine, Pain, and Opioid Use in Patients Taking High-Dose Long-Term Opioids: A Randomized Clinical Trial. JAMA Intern Med. 2025 Apr 1;185(4):372-381. doi: 10.1001/jamainternmed.2024.8361.
Derived from this study: PubMed 39652356Krebs EE, Becker WC, Nelson DB, DeRonne BM, Jensen AC, Kats AM, Morasco BJ, Frank JW, Makris UE, Allen KD, Naylor JC, Mixon AS, Bohnert A, Reznik TE, Painter JT, Hudson TJ, Hagedorn HJ, Manuel JK, Borsari B, Purcell N, Hammett P, Amundson EC, Kerns RD, Barbosa MR, Garvey C, Jones EJ, Noh MY, Okere JB, Bhushan S, Pinsonnault J, Williams BE, Herbst E, Lagisetty P, Librodo S, Mapara PS, Son E, Tat C, Marraffa RA, Seys RL, Baxley C, Seal KH; VOICE Study Group. Care Models to Improve Pain and Reduce Opioids Among Patients Prescribed Long-Term Opioid Therapy: The VOICE Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):208-220. doi: 10.1001/jamainternmed.2024.6683.
Derived from this study: PubMed 36384218Krebs EE, Becker WC, Nelson D, DeRonne BM, Nugent S, Jensen AC, Amundson EC, Manuel JK, Borsari B, Kats AM, Seal KH. Design, methods, and recruitment outcomes of the Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) study. Contemp Clin Trials. 2023 Jan;124:107001. doi: 10.1016/j.cct.2022.107001. Epub 2022 Nov 13.
Individual participant dataSharing planned: Yes. Data sharing procedures have not been finalized. At a minimum, a complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses of the study will be created and made available within one year after the completion of the study, pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Depending on feasibility and guidance from VA Office of Research Oversight, a Limited Dataset (LDS) may be created and shared. We have not yet determined how to operationalize data sharing for this study. In the interim, contact the PI for questions or requests.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Medication management, Non-pharmacological pain management and Buprenorphine-Naloxone in people with Chronic Pain, run by University of Minnesota at 1 site 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 2 inclusion and 5 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 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2023). 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?

Pain Response (time frame: 12 months). 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 NCT03026790, which also lists 4 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 5 Jun 2023.