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Digital Pain Management Interventions for Chronic Pain and Opioid Use Disorder
Phase 3
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Daily prescription opioid use (at least 10 morphine milliequivalent daily dose; MEDD) for at least 3 months
Chronic non-cancer pain (at least 6 months in duration)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment month 3
Awards & highlights
Study Summary
This trial will compare two digital interventions to reduce pain, opioid craving, and misuse in people with chronic pain & opioid misuse (N=220). Completion & satisfaction post-treatment will be measured. Surveys will be done at various points to track effects.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is not a drug trial but rather involves online-based interventions, typical medication side effects are not expected. However, there may be indirect effects like discomfort from engaging with the material or emotional responses to content.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been taking prescribed opioids daily for pain for at least 3 months.
Select...
I have had non-cancer pain for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-treatment month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioids
Opioid craving
Opioid use
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Empowered Relief On DemandExperimental Treatment1 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 Group1 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.
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,511 Total Patients Enrolled
55 Trials studying Chronic Pain
82,740 Patients Enrolled for Chronic Pain
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,130 Total Patients Enrolled
36 Trials studying Chronic Pain
9,013 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have been identified as misusing opioids based on a specific measure called the Current Opioid Misuse Measure (COMM).This criterion means that you need to have access to the internet.I have significant memory or thinking problems.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Health Education (HE; "Living Better")
- Group 2: Empowered Relief On Demand
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently accepted into the trial?
"Affirmative. According to the entry on clinicaltrials.gov, this scientific study is actively recruiting participants and was first posted on August 23rd 2023 with a most recent update of the same date. 220 individuals are required at 1 clinical site for completion of the trial."
Answered by AI
To what extent can Empowered Relief On Demand be potentially harmful to individuals?
"The safety of Empowered Relief On Demand is rated a 3 due to prior clinical evidence that supports its efficacy and the multiple rounds of data collected which further reinforces its safety."
Answered by AI
Are there any vacancies for prospective participants in this experiment?
"Affirmative. Clinicaltrials.gov hosts evidence that the trial, initiated on August 23rd 2023, is presently recruiting participants from a single site with an aim of enrolling 220 patients in total."
Answered by AI
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