PMID- 34217889
OWN - NLM
STAT- MEDLINE
DCOM- 20211124
LR  - 20221102
IS  - 1559-2030 (Electronic)
IS  - 1551-7144 (Print)
IS  - 1551-7144 (Linking)
VI  - 110
DP  - 2021 Nov
TI  - STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic 
      randomized trial of pain coping skills training and opioid medication taper 
      guidance for patients on long-term opioid therapy.
PG  - 106499
LID - S1551-7144(21)00235-4 [pii]
LID - 10.1016/j.cct.2021.106499 [doi]
AB  - High-dose, long-term opioid therapy (LtOT) is associated with risk for serious 
      harms. Rapid opioid discontinuation may lead to increased pain, psychological 
      distress, and illicit opioid use, but gradual, supported opioid taper may reduce 
      these risks. We previously demonstrated that an opioid taper support and pain 
      coping skills training intervention reduced opioid dose more than usual care (43% 
      vs 19% dose reduction from baseline), with no increase in pain intensity and a 
      significant reduction in activity interference. We aim to adapt and test this 
      intervention in the Kaiser Permanente Washington healthcare system with 
      STRategies to Improve Pain and Enjoy life (STRIPE, NCT03743402), a pragmatic, 
      randomized trial. Our goal was to randomize 215 participants on moderate-high 
      dose (>/=40 morphine milligram equivalent/day) LtOT to either cognitive-behavioral 
      therapy-based pain coping skills training involving 18 telephone sessions over 
      52 weeks with optional opioid taper support or usual care. Data are collected 
      from electronic health records, claims, and self-report. The primary outcomes are 
      mean daily opioid dose and the pain intensity, interference with enjoyment of 
      life, and interference with general activity (PEG) score at 12 months (primary 
      time point) and 6 months (secondary time point). Secondary outcomes include 
      having >/=30% opioid dose reduction from baseline, and patient-reported problem 
      opioid use, opioid-related difficulties, pain self-efficacy, opioid craving, 
      global impression of change, and anxiety and depressive symptoms at 6 and 
      12 months. If effective, this treatment could reduce opioid exposure and 
      associated risks to patients, families, and communities while offering patients 
      an alternative for managing pain.
CI  - Copyright (c) 2021 Elsevier Inc. All rights reserved.
FAU - Wartko, Paige D
AU  - Wartko PD
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United 
      States of America. Electronic address: Paige.D.Wartko@kp.org.
FAU - Boudreau, Denise M
AU  - Boudreau DM
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United 
      States of America; Department of Pharmacy, University of Washington, Seattle, WA, 
      United States of America; Department of Epidemiology, University of Washington, 
      Seattle, WA, United States of America.
FAU - Turner, Judith A
AU  - Turner JA
AD  - Department of Psychiatry & Behavioral Sciences, University of Washington, 
      Seattle, WA, United States of America.
FAU - Cook, Andrea J
AU  - Cook AJ
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United 
      States of America; Department of Biostatistics, University of Washington, 
      Seattle, WA, United States of America.
FAU - Wellman, Robert D
AU  - Wellman RD
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United 
      States of America.
FAU - Fujii, Monica M
AU  - Fujii MM
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United 
      States of America.
FAU - Garcia, Robin C
AU  - Garcia RC
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United 
      States of America.
FAU - Moser, Kathryn A
AU  - Moser KA
AD  - Kaiser Permanente Washington Health Research Institute, Seattle, WA, United 
      States of America.
FAU - Sullivan, Mark D
AU  - Sullivan MD
AD  - Department of Psychiatry & Behavioral Sciences, University of Washington, 
      Seattle, WA, United States of America.
LA  - eng
SI  - ClinicalTrials.gov/NCT03743402
GR  - R01 DA044970/DA/NIDA NIH HHS/United States
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20210702
PL  - United States
TA  - Contemp Clin Trials
JT  - Contemporary clinical trials
JID - 101242342
RN  - 0 (Analgesics, Opioid)
SB  - IM
MH  - Adaptation, Psychological
MH  - *Analgesics, Opioid/adverse effects
MH  - Humans
MH  - *Opioid-Related Disorders/drug therapy
MH  - Pain/drug therapy
MH  - Pain Management
MH  - Randomized Controlled Trials as Topic
PMC - PMC8595515
MID - NIHMS1727822
OTO - NOTNLM
OT  - Cognitive-behavioral therapy
OT  - Long-term opioid therapy
OT  - Opioids
OT  - Pain
OT  - Pain coping skills training
OT  - Taper
COIS- Declaration of interests Although we do not have any direct competing interests, 
      outside the work of this study, Paige Wartko, Denise Boudreau, and Monica Fujii 
      receive funding from a research contract awarded to Kaiser Permanente Washington 
      Health Research Institute from a consortium of pharmaceutical companies 
      (Allergan, BioDelivery Sciences, Collegium, Daiichi Sankyo, Depomed, Egalet, 
      Endo, Janssen, Mallinckrodt, Pernix, Pfizer, Purdue, and West-Ward) to conduct 
      Food and Drug Administration-mandated studies on opioids.
EDAT- 2021/07/05 06:00
MHDA- 2021/11/25 06:00
PMCR- 2022/11/01
CRDT- 2021/07/04 20:42
PHST- 2021/02/23 00:00 [received]
PHST- 2021/06/05 00:00 [revised]
PHST- 2021/06/28 00:00 [accepted]
PHST- 2021/07/05 06:00 [pubmed]
PHST- 2021/11/25 06:00 [medline]
PHST- 2021/07/04 20:42 [entrez]
PHST- 2022/11/01 00:00 [pmc-release]
AID - S1551-7144(21)00235-4 [pii]
AID - 10.1016/j.cct.2021.106499 [doi]
PST - ppublish
SO  - Contemp Clin Trials. 2021 Nov;110:106499. doi: 10.1016/j.cct.2021.106499. Epub 
      2021 Jul 2.