Mobile & Online-Based Interventions to Lessen Pain (MOBILE Relief) in People With Prescription Opioid Misuse

Who is this study for? Patients with Chronic Pain, Opioid Misuse Disorder
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Stanford University
RECRUITING
Palo Alto
Contact Information
Primary
Paige Palenski, BA
mobile_relief@stanford.edu
650-642-8303
Backup
Corinne Jung, PhD
cejung@stanford.edu
650-724-0522
Time Frame
Start Date: 2023-08-23
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 220
Treatments
Experimental: Empowered Relief On Demand
Empowered Relief On-Demand will include roughly 80 minutes of interactive and multimedia pain educational content that targets pain and stress self-regulation, pain medication misuse, a personalized plan for relief and an audio App for daily use.
Placebo_comparator: Health Education (HE; Living Better)
The HE arm is an interactive digital general health education intervention called Living Better that is devoid of specific content on pain, psychological skills, and has no active strategies or worksheets.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: Stanford University

This content was sourced from clinicaltrials.gov