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

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
VA Office of Research and Development
Study ID
NCT07361432
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain
  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) — BEHAVIORAL
    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.
  • Enhanced Treatment as Usual (ETAU) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 2, 2026
Status verified
Jan 2026
Primary completion
Jun 3, 2029
Completion
May 31, 2030

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMPACT
    Data from Veteran participants randomized to digital intervention (IMPACT)
  • Placebo Comparator: ETAU
    Data from Veteran participants randomized to ETAU (no access to IMPACT)

Primary Outcome Measure

PROMIS Pain Interference 6b [ Time Frame: 3-months post-randomization ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
R. Ross MacLean, PhD
[email protected]
203-932-5711
R. Ross MacLean, PhD (PRINCIPAL_INVESTIGATOR)
VA Bedford HealthCare System, Bedford, MABedfordMassachusetts01730-1114
Erin Reilly, PhD
[email protected]
781-687-4191
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Rebekah Harris, DPT
[email protected]
857-364-2785
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Shannon Nugent, PhD
[email protected]
503-220-8262

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