Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), Enhanced Treatment as Usual (ETAU).
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improving Pain and Functioning Using an Integrative Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
Overview
Chronic pain is common in individuals with opioid use disorder (OUD) and the first-line treatment, Medication for OUD (MOUD), does not address the considerable functional impairments associated with chronic pain. Veterans with OUD and chronic pain could benefit from integrated, behavioral treatment for chronic pain and addiction, but VHA MOUD clinics often lack the resources to offer these services. The proposed study will examine the effectiveness of an evidence-based digital chronic pain and addiction treatment that Veterans can do from home, which can provide a flexible option for Veterans to engage in treatment from home and the Veterans Health Administration (VHA) a means to provide care without placing trained clinicians at each facility.
Detailed description
The Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is a 9-week, web-based treatment supplemented with daily digital surveys that inform personalized weekly feedback messages for people with chronic pain and OUD receiving MOUD. IMPACT is an integration of two previously tested technology-based interventions developed in a prior NIH-funded trial. Typically, VHA pain treatment resources are greater than civilian healthcare settings; therefore, the comparator group (enhanced treatment as usual or ETAU) in the current trial is a necessary step to rigorously test IMPACT specifically within Veteran Health Administration (VHA) clinical care.
Interventions
- Behavioral Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)
The IMPACT program is a 9-module web-based treatment augmented with personalized weekly feedback from an expert coach for people with chronic pain and OUD receiving MOUD. - Behavioral Enhanced Treatment as Usual (ETAU)
ETAU is inclusive of medication management, groups, and individual treatment offered within the outpatient buprenorphine clinics at the study sites. Additionally, study staff will provide a a comprehensive list of pain, addiction and mental health treatment options that are specific to their VA facility.
Primary outcome measures
- PROMIS Pain Interference 6b [Time frame: 3-months post-randomization]
Secondary outcome measures (7)
- PROMIS Pain Interference 6b [Time frame: 6- and 9-months post randomization]
- Veterans Rand 12-Item Health Survey (VR-12) [Time frame: 3-months post-randomization]
- Activity Measure for Post-Acute Care (AM-PAC) [Time frame: 3-months post-randomization]
- PROMIS Sleep Disturbance 6a and Duration [Time frame: 3-months post randomization]
- Buprenorphine retention [Time frame: 3-months post randomization]
- Buprenorphine adherence [Time frame: 3-months post randomization]
- Non-prescribed opiate use [Time frame: 3-months post randomization]
Eligibility criteria
Inclusion criteria
- an ICD-11 OUD diagnosis in the VHA electronic health record (EHR)
- receipt of buprenorphine from outpatient addiction clinic with stable (i.e., unchanged in 2 weeks or since last injection) dose confirmed by the prescribing clinician. Both oral and injectable buprenorphine formulations will be eligible with dose stabilization required to isolate chronic pain from withdrawal-related pain associated with non-therapeutic dose
- presence of musculoskeletal pain that is bothersome or high-impact per the Graded Pain Scale - Revised
- access to a web-connected device to complete daily surveys and connect to IMPACT treatment site
- ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block
Exclusion criteria
- dementia-related EHR diagnosis
- participant-reported vision or hearing impairments that would preclude use of the IMPACT system
- legal actions that would make study completion unlikely
- current or past 12 month engagement in CBT for chronic pain treatment
- planned surgical intervention for pain
- physical or mental health conditions that would interfere with ability to meaningful engage in IMPACT and MOUD treatment (e.g., uncontrolled bipolar disorder, active suicidal ideation, receipt of hospice or end-of-life palliative care)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
- VA Bedford HealthCare System, Bedford, MA — Bedford
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston
- VA Portland Health Care System, Portland, OR — Portland
Identifiers
NCT: NCT07361432 · RRDA-001-25M · 1I01RD000376-01A1