643
Participants
Start Date
January 3, 2021
Primary Completion Date
December 21, 2023
Study Completion Date
May 31, 2024
Pain Coping Skills Training (PCST)
The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish.
Buprenorphine
At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
New York University, New York
VA NY Harbor Healthcare System, New York
Rogosin Institute, New York
University of Pittsburgh, Pittsburgh
University of Pennsylvania, Philadelphia
West Virginia University, Morgantown
Durham VA Healthcare System, Durham
Vanderbilt University Medical Center, Nashville
Hennepin County Medical Center, Minneapolis
University of Illinois at Chicago, Chicago
Dallas VA Medical Center, Dallas
University of New Mexico, Albuquerque
VA Portland Healthcare System, Portland
University of Washington, Seattle
West Haven VA Healthcare System, West Haven
Massachusetts General Hospital, Boston
Collaborators (2)
Hennepin Health Care
UNKNOWN
New York University
OTHER
Massachusetts General Hospital
OTHER
University of Illinois at Chicago
OTHER
University of Pittsburgh
OTHER
University of Washington
OTHER
University of New Mexico
OTHER
Rogosin Institute
UNKNOWN
Vanderbilt University Medical Center
OTHER
West Virginia University
OTHER
Yale University
OTHER
Durham VA Health Care System
FED
VA Portland Healthcare System
UNKNOWN
West Haven VA Medical Center
UNKNOWN
University of Pennsylvania
OTHER
Dallas VA Medical Center
FED
VA New York Harbor Healthcare System
FED
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH