Chronic PainPhase 3NCT05152134
Mobile & Online-Based Interventions to Lessen Pain
A Phase 3 study testing Empowered Relief On-Demand and Health Education in people with Chronic Pain and Opioid Misuse, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Misuse, Opioid Use Disorder
- What is being tested?
- Empowered Relief On-Demand and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 15 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile & Online-Based Interventions to Lessen Pain (MOBILE Relief) in People With Prescription Opioid Misuse
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.
Read the 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.
- Conditions
- Chronic Pain, Opioid Misuse, Opioid Use Disorder
- Being tested
- Empowered Relief On-Demand, Health Education
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered Relief On-DemandBehavioural
Tailored interactive digital health treatment for chronic pain
Health EducationBehavioural
The HE digital intervention is roughly 65 minutes with content discussing pain and health topics generally; it is devoid of pain education, psychological skills, and has no active strategies, worksheets, or supportive tools.
| Study group | Role | What they receive |
|---|---|---|
| Empowered Relief On Demand | Experimental | 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. Receives: Behavioral: Empowered Relief On-Demand |
| Health Education (HE; "Living Better") | Placebo comparator | 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. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Measured: baseline
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Measured: post-treatment week 1
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Measured: post-treatment week 2
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Measured: post-treatment month 1 (Multi-Primary Endpoint)
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Measured: post-treatment month 2
Pain intensity
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Measured: post-treatment month 3
Pain catastrophizing
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Measured: baseline
Pain catastrophizing
A brief 4-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-16 with higher scores indicating higher levels of pain catastrophizing.
Measured: post-treatment week 1
Pain catastrophizing
A brief 4-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-16 with higher scores indicating higher levels of pain catastrophizing.
Measured: post-treatment week 2
Pain catastrophizing
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Measured: post-treatment month 1 (Multi-Primary Endpoint)
Pain catastrophizing
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Measured: post-treatment month 2
Pain catastrophizing
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Measured: post-treatment months 3
Pain interference
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Measured: baseline
Pain interference
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Measured: post-treatment week 1
Pain interference
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Measured: post-treatment week 2
Pain interference
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Measured: post-treatment month 1 (Multi-Primary Endpoint)
Pain interference
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Measured: post-treatment month 2
Pain interference
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Measured: post-treatment month 3
Current prescription opioid misuse
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Measured: baseline
Current prescription opioid misuse
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Measured: post-treatment month 1 (Primary Endpoint)
Current prescription opioid misuse
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Measured: post-treatment month 2
Current prescription opioid misuse
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Measured: post-treatment month 3 (Secondary Endpoint)
Opioid craving
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Measured: baseline
Opioid craving
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Measured: post-treatment week 1
Opioid craving
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Measured: post-treatment week 2
Opioid craving
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Measured: post-treatment month 1 (Primary Endpoint)
Opioid craving
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Measured: post-treatment month 2
Opioid craving
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Measured: post-treatment months 3 (Secondary Endpoint)
Opioid use
Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).
Measured: Baseline to post-treatment month 3
Treatment engagement
Proportion of participants in both study arms that complete the brief treatment appraisal survey administered immediately after treatment
Measured: Immediately post-treatment (Primary Outcome)
Treatment appraisal
5 items assess satisfaction and perceived utility of assigned treatment (7-point scale where 0 = "not at all satisfied" to 6 = "extremely satisfied"). Higher scores indicate higher satisfaction with the assigned treatment.
Measured: Immediately post-treatment (Primary Outcome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start23 Aug 2023
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Beth Darnall, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152134
- Sponsor's protocol ID
- 61643
- Other IDs
- K24DA053564
- Status last verified
- Dec 2025
- First submitted
- 7 Oct 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edwards KA, Palenski P, Perez L, You DS, Ziadni MS, Jung C, Adair E, Tian L, Mackey SC, Darnall BD. Protocol for a randomised trial of a self-directed digital pain management intervention (Empowered Relief) tailored to adults with chronic pain and prescription opioid misuse/disorder: the MOBILE Relief study. BMJ Open. 2024 Aug 9;14(8):e086889. doi: 10.1136/bmjopen-2024-086889.
PubMed 39122392
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile & Online-Based Interventions to Lessen Pain (MOBILE Relief) in People With Prescription Opioid Misuse
- ClinicalTrials.gov ID
- NCT05152134
- Acronym / sponsor ID
- 61643
- Conditions
- Chronic Pain, Opioid Misuse, Opioid Use Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief On Demand | Experimental | Behavioral: Empowered Relief On-DemandEmpowered 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. |
| Health Education (HE; "Living Better") | Placebo comparator | Behavioral: Health EducationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered Relief On-DemandTailored interactive digital health treatment for chronic pain | Behavioural | Empowered Relief On Demand |
| Health EducationThe HE digital intervention is roughly 65 minutes with content discussing pain and health topics generally; it is devoid of pain education, psychological skills, and has no active strategies, worksheets, or supportive tools. | Behavioural | Health Education (HE; "Living Better") |
Primary outcome
Pain intensity
Time frame: baseline
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
Time frame: post-treatment week 1
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
Time frame: post-treatment week 2
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
Time frame: post-treatment month 1 (Multi-Primary Endpoint)
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
Time frame: post-treatment month 2
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain intensity
Time frame: post-treatment month 3
One validated item assessing average pain intensity for the past 7 days (0= "no pain" to 10= "worst pain imaginable").
Pain catastrophizing
Time frame: baseline
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Pain catastrophizing
Time frame: post-treatment week 1
A brief 4-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-16 with higher scores indicating higher levels of pain catastrophizing.
Pain catastrophizing
Time frame: post-treatment week 2
A brief 4-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-16 with higher scores indicating higher levels of pain catastrophizing.
Pain catastrophizing
Time frame: post-treatment month 1 (Multi-Primary Endpoint)
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Pain catastrophizing
Time frame: post-treatment month 2
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Pain catastrophizing
Time frame: post-treatment months 3
A 13-item scale used to quantify an individual's pain experience (5 point scale where 0 = "Not at all" and 4 = "All the time"). Scores range from 0-52 with higher scores indicating higher levels of pain catastrophizing.
Pain interference
Time frame: baseline
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Pain interference
Time frame: post-treatment week 1
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Pain interference
Time frame: post-treatment week 2
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Pain interference
Time frame: post-treatment month 1 (Multi-Primary Endpoint)
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Pain interference
Time frame: post-treatment month 2
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Pain interference
Time frame: post-treatment month 3
6 items assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. Responses range from 1 = "Not at all" to 5 = "Very much" with higher scores representing a greater degree of pain interference.
Current prescription opioid misuse
Time frame: baseline
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Current prescription opioid misuse
Time frame: post-treatment month 1 (Primary Endpoint)
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Current prescription opioid misuse
Time frame: post-treatment month 2
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Current prescription opioid misuse
Time frame: post-treatment month 3 (Secondary Endpoint)
17 items assessing opioid misuse thoughts and behaviors over the past 30 days. Four point response scale (0 = "never" to 4 = "very often") with higher scores representing more opioid misuse.
Opioid craving
Time frame: baseline
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Opioid craving
Time frame: post-treatment week 1
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Opioid craving
Time frame: post-treatment week 2
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Opioid craving
Time frame: post-treatment month 1 (Primary Endpoint)
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Opioid craving
Time frame: post-treatment month 2
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Opioid craving
Time frame: post-treatment months 3 (Secondary Endpoint)
1 item asking participants to indicate how much opioid craving they have experienced over the past week (0 = "no craving" to 10 = "strongest craving ever").
Opioid use
Time frame: Baseline to post-treatment month 3
Percent reduction (0-100%) of self-reported prescribed Morphine Equivalent Daily Dose (MEDD).
Treatment engagement
Time frame: Immediately post-treatment (Primary Outcome)
Proportion of participants in both study arms that complete the brief treatment appraisal survey administered immediately after treatment
Treatment appraisal
Time frame: Immediately post-treatment (Primary Outcome)
5 items assess satisfaction and perceived utility of assigned treatment (7-point scale where 0 = "not at all satisfied" to 6 = "extremely satisfied"). Higher scores indicate higher satisfaction with the assigned treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 39122392Edwards KA, Palenski P, Perez L, You DS, Ziadni MS, Jung C, Adair E, Tian L, Mackey SC, Darnall BD. Protocol for a randomised trial of a self-directed digital pain management intervention (Empowered Relief) tailored to adults with chronic pain and prescription opioid misuse/disorder: the MOBILE Relief study. BMJ Open. 2024 Aug 9;14(8):e086889. doi: 10.1136/bmjopen-2024-086889.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empowered Relief On-Demand and Health Education in people with Chronic Pain and Opioid Misuse, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: baseline). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152134, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.