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OpenTrials
Completed

NCT Number: NCT04746833

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT, West Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SUMMIT

Behavioral

multicomponent web-based application focused on pain self-management skills

Control

Behavioral

My Pain Diary app

Primary outcomes

  1. Daily Morphine Milligram Equivalents (MME)

    Time frame: 9-months

    Morphine milligram equivalents per day based on participant self report.

  2. Minutes of Summit App Use

    Time frame: 6 months

    Total number of minutes of use of the Summit app over the 6 month intervention

Secondary outcomes

  1. Behavior Intervention Rating Scale (BIRS)

    Time frame: six months

    The BIRS is a 24-item validated measure of an intervention's acceptability and perceived effectiveness scored on 5-point agreement scales. The total score is divided by the total number of completed items and this ranges from 1 to 5. Higher mean item scores represent higher acceptability.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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