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.


NCT ID:

NCT04746833


Primary Contact:

Principal Investigator
William C Becker, MD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Sara Edmond, PhD
Phone: (203) 932-5711 ext. 3288
Email: sara.edmond@va.gov


Backup Contact:

Email: William.Becker4@va.gov
William C Becker, MD
Phone: (203) 932-5711 ext. 2427


Location Contact:

Philadelphia, Pennsylvania 19104
United States

Manik Chhabra, MD
Email: manik.chhabra@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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