Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine

VA Office of Research and Development

Status and phase: Begins enrollment in 8 months; Phase 3

Conditions: Opioid Use Disorder; Chronic Pain

Treatments: Behavioral: Enhanced Treatment as Usual (ETAU); Behavioral: Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07361432

1I01RD000376-01A1 (Other Grant/Funding Number)

RRDA-001-25M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups, including a placebo group

IMPACT

Experimental group

Description:

Data from Veteran participants randomized to digital intervention (IMPACT)

Treatment:

Behavioral: Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)

ETAU

Placebo Comparator group

Description:

Data from Veteran participants randomized to ETAU (no access to IMPACT)

Treatment:

Behavioral: Enhanced Treatment as Usual (ETAU)