NCT03026790

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
820

participants targeted

Target at P75+ for phase_2 chronic-pain

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_2 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
7 months until next milestone

Results Posted

Study results publicly available

June 5, 2023

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

January 1, 2017

Results QC Date

March 31, 2023

Last Update Submit

May 7, 2023

Conditions

Chronic Pain

Keywords

Opioid analgesicsOpioid partial agonistsHealth care deliveryBack painOsteoarthritisVeterans health

Outcome Measures

Primary Outcomes (1)

  • Pain Response

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

    12 months

Secondary Outcomes (3)

  • 50% Reduction in Opioid Daily Dose

    12 months

  • Composite Response

    12 months

  • Brief Pain Inventory (BPI) Total Score

    12 months

Other Outcomes (10)

  • VR-12 Physical Component Score

    12 months

  • Symptom Checklist

    12 months

  • PODS Problems

    12 months

  • +7 more other outcomes

Study Arms (4)

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.

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.

Other: Medication managementOther: 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.

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.

Other: Medication managementDrug: Buprenorphine-Naloxone

Interventions

Medication managementOTHER

Individualized management of medications for pain

Expanded taper optionsIntegrated pain team (IPT)Standard taper optionsTelecare collaborative management (TCM)
Non-pharmacological pain managementOTHER

Individualized management of non-medication pain treatment approaches

Integrated pain team (IPT)
Buprenorphine-NaloxoneDRUG

Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation

Expanded taper options

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (3)

  • 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.

    PMID: 39960730DERIVED

  • 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.

    PMID: 39652356DERIVED

  • 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.

    PMID: 36384218DERIVED

MeSH Terms

Conditions

Chronic PainBack PainOsteoarthritis

Interventions

Medication Therapy ManagementBuprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMedicare Part DInsurance, Pharmaceutical ServicesInsurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsMedicarePatient Care ManagementHealth Services AdministrationBuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Erin Krebs
Organization
University of Minnesota
Erin.Krebs@va.gov
612-629-7558

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2017

First Posted

January 20, 2017

Study Start

October 19, 2017

Primary Completion

March 17, 2022

Study Completion

October 30, 2022

Last Updated

June 5, 2023

Results First Posted

June 5, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)