Digital Pain Management Interventions for Chronic Pain and Opioid Use Disorder

Overseen By Paige Palenski, BA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Must be taking: Opioids

Disqualifiers: Cognitive impairment, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Approximately 80 minutes

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online program called "Empowered Relief: On-Demand" (E-ROD) to assist individuals with chronic pain who also struggle with prescription opioid misuse. The goal is to determine if this digital tool can reduce pain and opioid cravings compared to a standard health education program that does not focus on pain or addiction. Participants will complete surveys to help researchers assess the program's effectiveness and usefulness. Individuals with chronic pain for over six months, who take opioids daily, and feel they misuse them might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to have been using prescription opioids daily for at least 3 months, so it seems you may need to continue your current opioid medication.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found the Empowered Relief On-Demand treatment to be safe, with no major safety issues reported. Research shows that this digital program helps people manage pain and stress without causing significant side effects. Although this treatment is still under evaluation, the current phase of the study focuses on confirming its safety and effectiveness. Earlier tests have already demonstrated its relative safety for use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial for Empowered Relief On-Demand because it offers a fresh approach to managing chronic pain and opioid use disorder. Unlike traditional treatments that often rely on medication, this digital intervention provides an interactive and multimedia experience aimed at self-regulating pain and stress. It includes a personalized relief plan and daily audio support, making it accessible and convenient for users. This method empowers patients to manage their pain effectively without the risks associated with long-term opioid use.

What evidence suggests that this trial's treatments could be effective for chronic pain and opioid use disorder?

Research has shown that the Empowered Relief On-Demand (E-ROD) treatment, available to participants in this trial, can help reduce pain and manage opioid cravings. Studies have found that digital programs like E-ROD effectively teach skills for handling pain and reducing opioid dependence. Users of these digital tools report feeling less pain and a reduced urge to misuse opioids. The treatment aids individuals in managing pain and stress, while also providing a personalized relief plan. Overall, early studies support its potential effectiveness in managing chronic pain and reducing opioid misuse. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic non-cancer pain lasting at least 6 months, who use prescription opioids daily and have misused them. Participants need internet access, an average pain intensity of ≥3, and must be fluent in English. Those with cognitive impairments or enrolled in another Empowered Relief study can't join.

Inclusion Criteria

I have been taking prescribed opioids daily for pain for at least 3 months.

Your average pain level is at least 3 on a pain scale.

I have had non-cancer pain for at least 6 months.

Exclusion Criteria

Inability to complete study electronic surveys

Cannot currently be enrolled in a study or trial with Empowered Relief as a treatment/intervention

I have significant memory or thinking problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Empowered Relief On-Demand intervention or the Living Better health education intervention

Approximately 80 minutes

Online intervention

Post-Treatment Assessment

Participants complete a brief post-treatment survey to assess treatment engagement and appraisal

Immediately post-treatment

Follow-up

Participants are monitored for opioid misuse behaviors, craving, pain intensity, and psychological status

3 months

Electronic surveys at weeks 1 and 2, and months 1, 2, and 3

What Are the Treatments Tested in This Trial?

Interventions

• E-ROD
• Health Education

Trial Overview The trial tests 'Empowered Relief: On-Demand', a digital intervention aimed to reduce pain and opioid misuse against a health education program. It's a randomized controlled trial where participants are assigned to one of the two interventions by chance.

How Is the Trial Designed?

Group I: Empowered Relief On Demand Experimental Treatment 1 Intervention

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.

Group II: Health Education (HE; "Living Better") Placebo Group 1 Intervention

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.

E-ROD is already approved in United States, Canada, United Kingdom for the following indications:

Approved in United States as Empowered Relief for:

• Chronic pain
• Prescription opioid misuse
• Opioid use disorder

Approved in Canada as Empowered Relief for:

• Chronic pain
• Prescription opioid misuse
• Opioid use disorder

Approved in United Kingdom as Empowered Relief for:

• Chronic pain
• Prescription opioid misuse
• Opioid use disorder

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Digital therapeutics, such as virtual reality apps, have been authorized by the FDA as effective treatments for chronic conditions like low back pain and can enhance the effectiveness of traditional medications like buprenorphine for opioid use disorder.

A review of randomized controlled trials showed that patients using digital interventions alongside opioid treatments generally reported better pain relief compared to those receiving standard care, highlighting the potential of these technologies in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunct Digital Interventions Improve Opioid-Based Pain Management: Impact of Virtual Reality and Mobile Applications on Patient-Centered Pharmacy Care. Giravi, HY., Biskupiak, Z., Tyler, LS., et al.[2022]

An interdisciplinary pain rehabilitation program (PRP) significantly improved pain severity, functioning, psychological symptoms, and emotional quality of life in 60 patients with chronic pain, demonstrating its effectiveness as a treatment option.

The program also reduced opioid use from 58% of patients at the start to 15% at discharge, and decreased opioid misuse risk, as indicated by a drop in misuse scores from above to below the cutoff for risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain rehabilitation's dual power: Treatment for chronic pain and prevention of opioid-related risks. Crouch, TB., Wedin, S., Kilpatrick, RL., et al.[2021]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

Behavioral approaches to managing chronic pain are proven to be effective and safe, yet they are often overlooked by medical professionals in favor of pharmacological treatments.

Internet-based interventions, including therapist-guided and unguided options, show promise in increasing the accessibility and use of behavioral pain management strategies, although there is significant variability in their design and empirical support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting them where they are: Using the Internet to deliver behavioral medicine interventions for pain. Rini, C., Williams, DA., Broderick, JE., et al.[2021]

In a pilot study involving 60 adults with chronic pain and opioid use disorder, participants who used an online pain self-management program reported significant reductions in pain interference, pain severity, opioid misuse, and depressive symptoms after 8 weeks.

The study highlights that a majority of participants initially used opioids due to pain, indicating that effective pain management strategies like this online program could be crucial in addressing both pain and opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in online pain self-management improves pain in adults on medication-assisted behavioral treatment for opioid use disorders. Wilson, M., Finlay, M., Orr, M., et al.[2019]

The EMPOWER trial is a randomized controlled study involving approximately 400 chronic pain patients on long-term opioid therapy, aiming to evaluate the effectiveness of a web-based self-management program (E-Health) in reducing opioid use and pain levels.

Preliminary evidence suggests that the E-Health program can help decrease self-reported morphine equivalent dose (MED) while also alleviating pain, addressing the challenges of opioid dependency and limited access to non-drug therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy. Winhusen, T., Wilson, M., Dolor, RJ., et al.[2023]

The ePEEP program, a telehealth adaptation of the Patient Education Empowerment Programme for chronic pain, was found to be acceptable and feasible for participants, indicating its potential as a valuable resource for pain management during the COVID-19 pandemic.

Participants reported significant benefits from ePEEP, including personal development, relationship building, and enhanced learning about pain, suggesting that telehealth can effectively support chronic pain management and empower individuals in their health journeys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"So, you must understand that that group changed everything": perspectives on a telehealth group intervention for individuals with chronic pain. Ernstzen, D., Keet, J., Louw, KA., et al.[2023]

Interdisciplinary pain rehabilitation programs (IPRPs) significantly improve both self-reported and performance-based functional outcomes in patients with chronic pain, regardless of whether they are using opioids or not, as shown in a study involving two cohorts over a 3-week treatment period.

The study found that improvements in function were evident immediately after treatment and persisted for at least 6 months, highlighting the effectiveness of IPRPs in helping patients discontinue opioid use while enhancing their physical and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Treatment Outcomes for an Interdisciplinary Pain Rehabilitation Program: Comparisons of Subjective and Objective Outcomes on the Basis of Opioid Use Status. Gilliam, WP., Craner, JR., Cunningham, JL., et al.[2022]

Approximately 32.9% of emergency department patients receiving opioid prescriptions were identified as 'at-risk' for abuse potential using the SOAPP-R screening tool, highlighting a significant concern for opioid misuse.

The SOAPP-R demonstrated a high negative predictive value (89%), suggesting it could be an effective screening tool to identify patients at low risk for opioid abuse in the emergency department setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of an opioid abuse screening tool and prescription drug monitoring data in the emergency department. Weiner, SG., Horton, LC., Green, TC., et al.[2022]

The EMPOWER study is addressing the urgent need for safe and effective strategies for tapering opioids in chronic pain patients, as current methods have high dropout rates and can increase patient distress.

A new consensus screening tool has been developed to help clinicians identify Opioid Use Disorder (OUD) and assess its severity, which is crucial for determining appropriate treatment pathways for patients on long-term opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol. You, DS., Mardian, AS., Darnall, BD., et al.[2021]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

The EMPOWER study is a comprehensive, multi-state, randomized controlled trial designed to help patients with chronic pain safely reduce long-term opioid use through three different approaches: cognitive behavioral therapy, self-management, and usual care.

By collecting detailed patient-reported data and using real-time feedback, the study aims to provide valuable insights into the effectiveness of these methods for opioid tapering, ultimately improving patient outcomes and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol. Darnall, BD., Mackey, SC., Lorig, K., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11937707/

Zoom-Delivered Empowered Relief for Chronic Pain Of those few studies, results consistently show heightened daily-level associations among pain catastrophizing, pain, and opioid craving and use [39,41-43].

2. bmjopen.bmj.com bmjopen.bmj.com/content/14/8/e086889

Protocol for a randomised trial of a self-directed digital pain ... The purpose of the Mobile and Online-Based Interventions to Lessen Pain (MOBILE Relief) study is to compare a one-session, video-based, on-demand digital pain ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39122392/

Protocol for a randomised trial of a self-directed digital pain ... The purpose of the Mobile and Online-Based Interventions to Lessen Pain (MOBILE Relief) study is to compare a one-session, video-based, on-demand digital pain ...

4. formative.jmir.org formative.jmir.org/2025/1/e68292

Zoom-Delivered Empowered Relief for Chronic Pain This study examined the impact of Zoom-delivered ER among people with chronic pain on long-term opioid therapy.

5. withpower.com withpower.com/trial/phase-2-chronic-pain-3-2022-3900c

Digital Pain Management Interventions for Chronic ... This Phase 3 medical study run by Stanford University is evaluating whether E-ROD will have tolerable side effects & efficacy for patients with Opioid Abuse ...