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SUMMIT Tool for Chronic Pain
Phase 2 & 3
Waitlist Available
Led By William C Becker, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9-months
Awards & highlights
Study Summary
This trial is testing a mobile website to help veterans with chronic pain safely taper opioids while managing their pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
opioid dose
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SUMMITExperimental Treatment1 Intervention
Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.
Group II: controlPlacebo Group1 Intervention
Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SUMMIT
2021
Completed Phase 3
~50
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,623 Previous Clinical Trials
3,324,733 Total Patients Enrolled
39 Trials studying Chronic Pain
4,713 Patients Enrolled for Chronic Pain
William C Becker, MDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 Previous Clinical Trials
4,841 Total Patients Enrolled
1 Trials studying Chronic Pain
7 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking liquid methadone or buprenorphine for opioid use disorder or you have switched to buprenorphine for chronic pain. You have hearing or vision problems that are not corrected with hearing aids or glasses. You have mental health or cognitive problems or are currently participating in another study related to pain or opioids.
Research Study Groups:
This trial has the following groups:- Group 1: control
- Group 2: SUMMIT
Awards:
This trial has 0 awards, including: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.
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