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Single Session Class to Reduce Opioid Use in Chronic Pain

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Catastrophizing Class
Health Education
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-80 years of age
  • Diagnosis of chronic non-cancer pain (> 3 months in duration)
  • Currently using prescription opioids ≥ 20mg morphine equivalent daily dose (MEDD) for ≥ 3 months;
  • Ability and willingness to complete study procedures.

Exclusion Criteria:

  • Open litigation regarding a medical condition
  • Inability to provide informed consent and complete study procedures
  • Active suicidality.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pain Catastrophizing Class

Health Education

Arm Description

A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials.

A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community.

Outcomes

Primary Outcome Measures

Opioid Use
Clinically minimal reduction is defined as >15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)

Secondary Outcome Measures

Pain Catastrophizing Score; measured with Pain Catastrophizing Scale
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. We aim to obtain >30% reduction in PCS scores after the intervention

Full Information

First Posted
May 10, 2019
Last Updated
May 12, 2022
Sponsor
Stanford University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03950791
Brief Title
Single Session Class to Reduce Opioid Use in Chronic Pain
Official Title
Single Session Pain Catastrophizing Class: Efficacy & Mechanisms for Reducing Opioid Use Among Chronic Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Prescription opioids are one of the most commonly used treatments for chronic pain, despite limited evidence of their efficacy and high morbidity and mortality risks. The study aims to determine the efficacy of a targeted single-session psychology class in reducing opioid use among patients with chronic pain. The information gained from this study has the potential to identify patients who achieve a meaningful reduction in opioid use and inform opioid reduction strategies.
Detailed Description
The opioid epidemic is a serious national crisis that affects public health as well as social and economic welfare, with increasing and alarming mortality rates in the United States. Consequently, there is an urgent need for effective and efficient interventions to address opioid use to prevent the risk of opioid misuse and better address it once it is established. One of the greatest predictors for increased opioid use among patients with chronic pain is pain catastrophizing (PC), defined as persistent negative cognitive and emotional responses to actual or anticipated pain. Untreated PC can lead to increased opioid use and facilitate the risk for misuse and overuse of medications, particularly when surgery and pharmacologics are the focal medical care plan. Despite critical need, there are no targeted interventions that efficiently address the key psychological factors that can amplify both pain, need for opioids, and increased risk for misuse. This project aims to address this urgent need for efficient and effective solutions. A 2-hour targeted, single-session pain catastrophizing class (PC-class) has been developed, rooted in cognitive-behavior therapy (CBT) approaches, aimed at reducing opioid use by reducing pain catastrophizing in chronic pain. This targeted, brief treatment obviates many of the existing barriers and burdens to usual comprehensive pain-CBT, such as the time required to attend 8 sessions, insurance coverage, travel costs, lack of skilled clinicians, patient attrition, and copayments. The investigators will implement a randomized controlled trial comparing the PC-class to a health education control class. Aim 1, To determine the efficacy of the PC class in reducing opioid use among patients with mixed-etiology pain conditions. Aim 2, To collect daily data that will allow the conduct of analyses on the daily experience of catastrophizing and how it relates to opioid use, as well as its dynamic response to treatment. The investigators will use this daily data to characterize the mechanistic influence of catastrophizing on opioid use both on the daily-level and prospectively. Patient outcomes will be longitudinally tracked at 1, 3, 6, and 12 months after the intervention session. This project aims to identify patients who achieve a meaningful reduction in opioid use, which will enable better characterization of treatment responders and refining opioid reduction strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Catastrophizing Class
Arm Type
Experimental
Arm Description
A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials.
Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community.
Intervention Type
Behavioral
Intervention Name(s)
Pain Catastrophizing Class
Intervention Description
A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. It will also include mind-body science as it relates to pain and PC. Participants learn how to identify catastrophizing in the moment, and how to self-treat it. During the class, participants acquire skills and develop a plan to apply the learned skills to decrease physiological hyperarousal within the context of PC. Participants also acquire skills that improve the regulation of cognition and emotion, including PC reframing and thought restructuring, and develop a plan for implementing these skills in daily life. Finally, participants develop a plan to use behaviors that modulate attention and counteract helplessness.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Education about improving lifestyle factors to improve participants' overall health.
Primary Outcome Measure Information:
Title
Opioid Use
Description
Clinically minimal reduction is defined as >15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Score; measured with Pain Catastrophizing Scale
Description
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing. We aim to obtain >30% reduction in PCS scores after the intervention
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-80 years of age Diagnosis of chronic non-cancer pain (> 3 months in duration) Currently using prescription opioids ≥ 20mg morphine equivalent daily dose (MEDD) for ≥ 3 months; Ability and willingness to complete study procedures. Exclusion Criteria: Open litigation regarding a medical condition Inability to provide informed consent and complete study procedures Active suicidality.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maisa Ziadni, PhD
Phone
3137250615
Email
mziadni@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lluvia Gonzalez, BS
Phone
650-725-0450
Email
lluviagc@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maisa Ziadni, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maisa Ziadni
Phone
313-725-0615
Email
mziadni@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32532346
Citation
Ziadni MS, Chen AL, Winslow T, Mackey SC, Darnall BD. Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):521. doi: 10.1186/s13063-020-04415-x.
Results Reference
derived

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Single Session Class to Reduce Opioid Use in Chronic Pain

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