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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: IMPACTExperimental treatment 1 intervention
Group B: ETAUPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

PROMIS Pain Interference 6b

T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to less pain interference).

Time frame
3-months post-randomization

Secondary outcomes

1

PROMIS Pain Interference 6b

T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less pain interference).

Time frame
6- and 9-months post randomization
2

Veterans Rand 12-Item Health Survey (VR-12)

T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to better quality of life).

Time frame
3-months post-randomization
3

Activity Measure for Post-Acute Care (AM-PAC)

Measure has two scales: Basic Mobility (range: 0-24) and Daily Activity (range: 0-24); on both scales higher scores corresponds to better performance.

Time frame
3-months post-randomization
4

PROMIS Sleep Disturbance 6a and Duration

T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less sleep disturbance).

Time frame
3-months post randomization

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: