Philadelphia, Pennsylvania 19104

  • Chronic Pain

Purpose:

There are nearly one million veterans being treated with long-term opioid therapy (LTOT) for chronic pain. Numerous short and long-term harms associated with LTOT and mounting evidence suggest they have modest or no benefit. Yet, currently available resources to support veterans to taper are inadequate. Primary care, where most LTOT in VHA is prescribed, is overburdened and straining to meet the challenge of caring for patients with chronic pain. A scalable, relatively inexpensive tapering intervention to support primary care and/or to extend the reach of resource-intensive specialty clinics would be of great benefit to veterans who are not deriving sufficient benefit from LTOT. As such, the goal of this study is to develop and test an interactive, theory-informed, multi-component mobile website to enable veterans to safely taper opioids while managing their pain.


Study summary:

The investigators will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial of the multicomponent mobile website called SUMMIT. Eligible participants will be randomized to SUMMIT versus a pain monitoring app. Outcome measures will be collected over 9 months. To ensure rigor and successful future implementation, the investigators will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a User Centered Design - with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions.


Criteria:

Inclusion Criteria: Inclusion criteria for Veterans will be primary care patients who are dispensed 84 consecutive days of a stable dose of opioids (reflecting three consecutive 28-day prescriptions) through primary care and who report stable levels of pain intensity over the past month. Exclusion Criteria: Exclusion criteria will be Veterans on liquid methadone or buprenorphine for opioid use disorder (OUD) and those who have transitioned to buprenorphine (transdermal or sublingual) for chronic pain, have hearing or visual impairments (not corrected with hearing aids or glasses), psychiatric conditions, cognitive impairments, or participating in a concurrent pain or opioid-related research study.


Study is Available At:


Original ID:

IIR 17-228


NCT ID:

NCT04746833


Secondary ID:


Study Acronym:


Brief Title:

Development/Testing of SUMMIT: a Tool to Help Patients Manage Pain While Tapering Opioids


Official Title:

Development and Pilot Testing of LIMIT: a Multicomponent Tool to Support Opioid Tapering


Overall Status:

Recruiting


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Office of Research and Development


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

64


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:William C Becker, MD
Principal Investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Primary Contact:Sara Edmond, PhD
(203) 932-5711 ext. 3288
(203) 932-5711
sara.edmond@va.gov
Backup Contact:William C Becker, MD
(203) 932-5711 ext. 2427
(203) 932-5711
William.Becker4@va.gov

Study Dates

Start Date:March 24, 2021
Completion Date:September 22, 2022
Completion Type:Anticipated
Primary Completion Date:March 23, 2022
Primary Completion Type:Anticipated
Verification Date:May 2021
Last Changed Date:May 18, 2021
First Received Date:February 4, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:opioid dose
Time Frame:9-months
Safety Issues:False
Description:Daily dose of opioid analgesics taken, by participant self report.

Study Interventions

Intervention Type:Behavioral
Name:SUMMIT
Description:multicomponent web-based application focused on pain self-management skills
Arm Name:SUMMIT
Intervention Type:Behavioral
Name:control
Description:My Pain Diary app
Arm Name:control

Study Arms

Study Arm Type:Experimental
Arm Name:SUMMIT
Description: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 t
Study Arm Type:Placebo Comparator
Arm Name:control
Description: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

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Office of Research and Development

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Becker WC. "Clues" That Patients May Be Willing to Consider Opioid Reductions. J Gen Intern Med. 2020 Jun;35(6):1629-1630. doi: 10.1007/s11606-020-05712-6.
PMID:32221855

Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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