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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746833
• Other study ID #: IIR 17-228
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 24, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 30, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• SUMMIT
multicomponent web-based application focused on pain self-management skills
• control
My Pain Diary app

Locations

Country	Name	City	State
United States	VA Central Western Massachusetts Healthcare System, Leeds, MA	Leeds	Massachusetts
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid dose	Daily dose of opioid analgesics taken, by participant self report.	9-months