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NCT07361432
Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
Conditions: Opioid Use Disorder, Chronic Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 250
Sponsor: VA Office of Research and Development
Location: VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* an ICD-11 opioid use disorder (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 Integrating the Management of Pain and Addiction via Collaborative Treatment (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 electronic health record (EHR) diagnosis
* participant-reported vision or hearing impairments that would preclude use of the Integrating the Management of Pain and Addiction via Collaborative Treatment (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 Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) and Medication for OUD (MOUD) treatment (e.g., uncontrolled bipolar disorder, active suicidal ideation, receipt of hospice or end-of-life palliative care)
Source: ClinicalTrials.gov (NCT07361432). StuddyBuddy aggregates publicly available trial information.