Clinical trial NCT05152134: Mobile & Online-Based Interventions to Lessen Pain
Official title: Mobile & Online-Based Interventions to Lessen Pain (MOBILE Relief) in People With Prescription Opioid Misuse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Pain
Opioid Misuse
Opioid Use Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will implement an international 2-arm online pragmatic feasibility randomized controlled trial (RCT) of a digital pain relief skills intervention "Empowered Relief: On-Demand" to reduce pain metrics, opioid craving, and opioid misuse. They will compare Empowered Relief to a no-skills digital health education ("Living Better") intervention in community-based individuals with comorbid chronic pain and prescription opioid misuse (N=220). Completion of the brief post-treatment survey is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with three items (satisfaction, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, immediately post-treatment; at post-treatment weeks 1 and 2; and months 1, 2, and 3.

Detailed description: Most people who misuse prescription opioids report doing so for pain relief. This study will investigate a digital intervention for people with comorbid chronic pain and opioid misuse.

The intervention, Empowered Relief On-Demand, will include roughly 80 minutes of interactive digital pain education and pain management skills content with multimedia features and an App. The investigators will conduct a fully online 2-arm RCT of digital Empowered Relief in a national sample of people with comorbid chronic pain and opioid misuse compared to a digital health education control (HE).

The investigators will implement The MOBILE Relief Study, an international (United States, Canada, United Kingdom, and Australia) 2-arm online feasibility RCT of Empowered Relief to reduce pain intensity, pain interference, pain-related distress (pain outcomes) and opioid outcomes (opioid craving and misuse) in people with prescription opioid misuse and chronic pain. They will compare Empowered Relief On Demand to an interactive digital health education (HE) intervention that is devoid of pain management skills ("Living Better") in community-based individuals with comorbid chronic pain and prescription opioid misuse (N=220). Completion of the brief post-treatment survey (received immediately following treatment completion) is a binary measure of treatment engagement; treatment feasibility and appraisal are assessed with five items (overall satisfaction with treatment, ease of understanding, relevance, perceived utility, and likelihood to use skills learned). Electronic surveys will measure opioid misuse behaviors, craving, and use; and pain intensity and psychological status at: baseline, and months 1, 2, and 3. At post-treatment weeks 1 and 2, electronic surveys will measure opioid craving, pain intensity, pain catastrophizing (distress), and pain interference.

Eligibility criteria: Inclusion Criteria:

* Male and females 18 years of age or older
* Chronic non-cancer pain (at least 6 months in duration)
* Average pain intensity of at least 3 on the PROMIS SFV1.0 Pain Intensity 1a
* Daily prescription opioid use (at least 10 morphine milliequivalent daily dose; MEDD) for at least 3 months
* Opioid misuse (at least 6 on the Current Opioid Misuse Measure; COMM)
* English fluency
* Internet access

Exclusion Criteria:

* Gross cognitive impairment
* Inability to complete study electronic surveys
* Cannot currently be enrolled in a study or trial with Empowered Relief as a treatment/intervention

Primary outcomes:
measure: Pain intensity
timeFrame: baseline
measure: Pain intensity
timeFrame: post-treatment week 1
measure: Pain intensity
timeFrame: post-treatment week 2
measure: Pain intensity
timeFrame: post-treatment month 1 (Multi-Primary Endpoint)
measure: Pain intensity
timeFrame: post-treatment month 2
measure: Pain intensity
timeFrame: post-treatment month 3
measure: Pain catastrophizing
timeFrame: baseline
measure: Pain catastrophizing
timeFrame: post-treatment week 1
measure: Pain catastrophizing
timeFrame: post-treatment week 2
measure: Pain catastrophizing
timeFrame: post-treatment month 1 (Multi-Primary Endpoint)
measure: Pain catastrophizing
timeFrame: post-treatment month 2
measure: Pain catastrophizing
timeFrame: post-treatment months 3
measure: Pain interference
timeFrame: baseline
measure: Pain interference
timeFrame: post-treatment week 1
measure: Pain interference
timeFrame: post-treatment week 2
measure: Pain interference
timeFrame: post-treatment month 1 (Multi-Primary Endpoint)
measure: Pain interference
timeFrame: post-treatment month 2
measure: Pain interference
timeFrame: post-treatment month 3
measure: Current prescription opioid misuse
timeFrame: baseline
measure: Current prescription opioid misuse
timeFrame: post-treatment month 1 (Primary Endpoint)
measure: Current prescription opioid misuse
timeFrame: post-treatment month 2
measure: Current prescription opioid misuse
timeFrame: post-treatment month 3 (Secondary Endpoint)
measure: Opioid craving
timeFrame: baseline
measure: Opioid craving
timeFrame: post-treatment week 1
measure: Opioid craving
timeFrame: post-treatment week 2
measure: Opioid craving
timeFrame: post-treatment month 1 (Primary Endpoint)
measure: Opioid craving
timeFrame: post-treatment month 2
measure: Opioid craving
timeFrame: post-treatment months 3 (Secondary Endpoint)
measure: Opioid use
timeFrame: Baseline to post-treatment month 3
measure: Treatment engagement
timeFrame: Immediately post-treatment (Primary Outcome)
measure: Treatment appraisal
timeFrame: Immediately post-treatment (Primary Outcome)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: