Clinical trial NCT05051644: An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
Official title: An Adaptive Walking Intervention to Manage Chronic Pain in Veterans With Opioid Use Disorder Engaged in Opioid Agonist Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Opioid Use Disorder
Chronic Pain
Keywords: Chronic Pain
Opioid Use Disorder
opioid agonist treatment
medications for opioid use disorder
methadone
buprenorphine
walking
exercise
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Recruitment strategies will week to minimize the amount of time between screening visit and treatment start date. After completing screening visit, Veterans will begin a 7 day baseline EMA run-in period leading up to the start of the treatment week. First treatment session will be scheduled 7 days after screening visit. The feasibility of these procedures will be evaluated in Aim 1. Veterans who provide pedometer and EMA survey data on at least 3 days during baseline EMA will be randomized. Veterans will be randomized to either S2C or control in a 1:1 ratio using permuted block randomization stratified by OAT type (1=buprenorphine, 2=methadone) and sex (1=male, 2=female). A variable block size of 2 and 4 will be used to maintain balanced assignment to condition.
Primary purpose: TREATMENT

Brief summary: Severe chronic pain and opioid use disorder (OUD) occur at significantly higher rates in Veterans compared to the general population. Chronic pain often persists despite engagement in opioid agonist treatment (OAT), the first line treatment for OUD. Recent VA guidelines strongly recommend non-pharmacologic treatment for chronic pain, but individuals with OUD are frequently excluded from pain treatment studies. There is a need for evidence-based pain treatments that compliment OAT for Veterans with chronic pain and OUD. In this study, the investigators will determine feasibility and acceptability for a behaviorally focused pain treatment that includes pain education and a pedometer assisted adaptive walking program for Veterans receiving OAT for OUD. Potential treatment outcomes will be repeatedly assessed using a mobile device, and study-provided pedometers. By offering pain treatment within OAT clinical care, the investigators hope to decrease stigma and increase access for Veterans with chronic pain and OUD.

Detailed description: The proposed study will address the pain treatment knowledge gap in Veterans with opioid use disorder (OUD) by piloting a behaviorally-based walking pain treatment for Veterans with chronic pain and OUD. Steps to Change (S2C) is a pain-focused treatment comprised of weekly 60-minute treatment sessions held over four consecutive weeks within the a Veterans Health Administration opioid agonist treatment (OAT) clinic. To date, no study has evaluated a pedometer-assisted walking program in individuals with chronic pain and OUD engaged in OAT. Topics for S2C include biopsychosocial pain education, pacing activities, benefits of physical activity, and an adaptive walking program derived from Cognitive Behavioral Therapy for chronic pain (CBT-CP) modules. The control will be matched for treatment exposure and attention. Veterans in both conditions will be provided a pedometer to record daily step counts as an objective measure of physical activity. Importantly, pain is a dynamic process that is known to vary over time and context. Veterans in both conditions will complete ecological momentary assessment (EMA) surveys, where behavior is repeatedly sampled using a mobile device. The primary treatment outcome (i.e., pain interference) will be collected using EMA. The use of EMA offers considerable benefits relative to in-clinic measurement including significantly reducing recall bias and substantially improving reliability of measurement. For example, compared to a single rating, a composite of five daily pain ratings over 2 weeks increased reliability from 0.65 to 0.90.55 Importantly, multiple studies have demonstrated that repeatedly asking about pain (e.g., 3 to 12 prompts per day for 2 weeks) does not increase pain reactivity.

The study objectives align closely with the description of a Stage IB pilot trial. Stage IB research determines feasibility and pilot testing of an adaptation or refinement of an existing intervention. Walking is a core component of CBT-CP and physical activity has a strong evidence base as a pain treatment for individuals with chronic pain; however, a walking program for chronic pain has not been evaluated in Veterans with chronic pain and OUD receiving OAT. Aim 1 will determine feasibility of study procedures including randomization, retention, fidelity, and proposed study outcomes of S2C and control conditions. Evaluating the feasibility of treatment and best practices for how quickly Veterans can be screened, consented, and randomized to start treatment is a critical step to inform a larger Stage II efficacy trial. In addition, the investigators will evaluate treatment attendance and retention in both S2C and control conditions to determine feasibility as well as discrimination of conditions for fidelity. The investigators will also collect data on mobile phone ownership and compare EMA survey response rates between conditions to inform future efficacy studies. The investigators expect that treatment attendance, retention, and survey responses for S2C will be equal to or superior then control. Aim 2 will establish acceptability of S2C and health education control by assessing intervention credibility and satisfaction at post-treatment. The investigators expect that Veterans in both conditions will report treatment as credible and satisfying. Since S2C is explicitly intended to increase daily step count, credibility of S2C will also be evaluated by expect greater increases (compared to control) in mean daily step count from baseline to post-treatment. Finally, Aim 3 will determine preliminary efficacy for whether S2C, compared to control, reduces pain interference assessed via EMA. Primary endpoint will be at post-treatment, but the investigators will also evaluate durability or sleeper effects on pain interference assessed via EMA at 3- and 6-month follow up.

Eligibility criteria: Inclusion Criteria:

* Meet DSM5 criteria for OUD and receiving stable (i.e., unchanged in 2 weeks) dose of OAT (i.e., buprenorphine or methadone) in VACHS outpatient addiction clinic
* Report high impact or bothersome chronic pain defined by experiencing pain on most days or every day in the past 3 months that limits general activity or enjoyment
* Self-reported ability to walk 1 block
* Access to a mobile phone with active data plan

Exclusion Criteria:

* Untreated major psychiatric disorders (e.g., bipolar disorder, psychotic disorder)
* Current (i.e., past month) active suicidal ideation
* Substance use disorder requiring inpatient detoxification
* Currently engaged in CBT for chronic pain treatment
* Planned surgical intervention for pain

Primary outcomes:
measure: Retention
timeFrame: Up to 5 weeks
measure: Acceptability
timeFrame: Up to 5 weeks
measure: Fidelity
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Pain interference
timeFrame: Up to 5 weeks
Other outcomes:
measure: Pain interference
timeFrame: 3-month and 6-month follow up
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: R. Ross MacLean, PhD
role: PRINCIPAL_INVESTIGATOR
References: