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Pain Catastrophizing and Prescription Opioid Craving

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping Statement
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years
  • Chronic pain ( > 3months)
  • Prescription opioid use (>3 months)

Exclusion Criteria:

  • Current diagnosis of cancer
  • Concurrent psychological therapy
  • Other severe psychiatric conditions (schizophrenia, delusional disorder, psychotic disorder, dissociative disorder, and active suicidality)
  • Any skin conditions on the hand (pain testing site)
  • Non-English speaker
  • No access to email or smart phone

Sites / Locations

  • SNAPLRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coping statement

Control

Arm Description

Daily practice of pain coping statements for 7 days

No instruction about pain coping statement.

Outcomes

Primary Outcome Measures

craving
Visual analogue scale 0-100 will be used to measure daily craving
craving
Visual analogue scale 0-100 will be used to measure daily craving

Secondary Outcome Measures

Cortisol
Salivary cortisol will be collected at wake up, 30-min after waking up, and 9pm
Cortisol
Salivary cortisol will be collected at wake up, 30-min after waking up, and 9pm
Anxiety symptoms
Patient-Reported Outcomes Measurement Information System-Anxiety item bank will be administered
Anxiety symptoms
Patient-Reported Outcomes Measurement Information System-Anxiety item bank will be administered
Depression symptoms
Patient-Reported Outcomes Measurement Information System-Depression item bank will be administered
Depression symptoms
Patient-Reported Outcomes Measurement Information System-Depression item bank will be administered
Prescription opioid misuse
Current Opioid Misuse Measure will be administered

Full Information

First Posted
September 17, 2019
Last Updated
August 10, 2023
Sponsor
Stanford University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04097743
Brief Title
Pain Catastrophizing and Prescription Opioid Craving
Official Title
Effect of Pain Catastrophizing on Prescription Opioid Craving
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (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
No

5. Study Description

Brief Summary
Adherence to prescription opioid and opioid tapering as indicated are critical for safe chronic opioid therapy for chronic pain, but this can be difficult for patients experiencing prescription opioid craving. Because pain catastrophizing is proposed as a possible treatment target by our and others' preliminary results, the proposed study aims to determine whether pain catastrophizing is a treatment target to reduce prescription opioid craving and to investigate whether negative affect and stress hormones are potential mediators. The findings from the current study will inform whether a psychology intervention to lower pain catastrophizing will reduce opioid craving, and whether psychological and physical distress as well as cognitive function will be potential mediators of the treatment effect.
Detailed Description
Chronic pain and opioid overdose are two critical public health problems in the US. About 25 million adults (11%) suffer from chronic daily pain and up to 8 million use opioids to manage chronic pain. Unfortunately, 46 people die daily from overdose of prescription opioids. For safe chronic opioid therapy for chronic pain, physicians monitor patients' adherence to prescription opioids, and reduce or discontinue the prescription as indicated. Yet, adherence and cessation are not easy for some patients and one reason is opioid craving, a strong desire or urge to use opioids. Our preliminary data show about 34% of patients on chronic opioid therapy report craving. Craving is strongly associated with opioid misuse and negative health outcomes. To date, we do not fully understand the underlying mechanisms of prescription opioid craving in chronic pain sufferers, and psychological treatment targets to reduce craving. Based on our pilot survey, patients endorsing craving reported greater pain catastrophizing than those endorsing no craving. Our other survey study also reported a positive link between pain catastrophizing and opioid craving in patients on chronic opioid therapy for chronic pain conditions. Although these findings propose a possibility that lowering pain catastrophizing may decrease opioid craving, cross-sectional observational studies are limited in investigating a causal association. Potentially, pain catastrophizing enhances stress-induced opioid craving because stress-induced opioid craving is a well-established phenomenon in studies of addiction, and pain catastrophizing is associated with greater pain and emotional distress in patients with chronic pain. Therefore, the proposed project seeks to determine: a) the effect of pain catastrophizing on prescription opioid craving in patients on chronic opioid therapy for chronic pain and b) psychological (negative affect) and physiological (cortisol, norepinephrine) distress and cognitive function as potential mediating variables. The proposed study will use the previously validated protocol to temporarily induce and reduce pain catastrophizing and assess changes in opioid craving, negative affect, and stress hormones before and after pain catastrophizing manipulation. Additionally, this proposed study prospectively administers the protocol to reduce pain catastrophizing by thinking about and rehearsing a coping statement daily for 7 days and monitor daily opioid craving, opioid use and misuse, and negative affect for 14 days. The current project is expected to characterize the role of pain catastrophizing in opioid craving and opioid misuse, and pain catastrophizing as a critical psychological treatment target for reducing prescription opioid craving and improving prescription adherence. Furthermore, the protocol to manipulate pain catastrophizing can facilitate future research to study causal mechanisms involved in pain catastrophizing and the protocol to rapidly stabilize pain catastrophizing can be used clinically to improve the health outcome of patients taking prescription opioid for chronic pain.

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
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coping statement
Arm Type
Experimental
Arm Description
Daily practice of pain coping statements for 7 days
Arm Title
Control
Arm Type
No Intervention
Arm Description
No instruction about pain coping statement.
Intervention Type
Behavioral
Intervention Name(s)
Coping Statement
Intervention Description
Daily practice of coping statement
Primary Outcome Measure Information:
Title
craving
Description
Visual analogue scale 0-100 will be used to measure daily craving
Time Frame
At day 7 (after intervention)
Title
craving
Description
Visual analogue scale 0-100 will be used to measure daily craving
Time Frame
At day 14 (7 days after intervention)
Secondary Outcome Measure Information:
Title
Cortisol
Description
Salivary cortisol will be collected at wake up, 30-min after waking up, and 9pm
Time Frame
At day 7 (after intervention)
Title
Cortisol
Description
Salivary cortisol will be collected at wake up, 30-min after waking up, and 9pm
Time Frame
At day 14 (7 days after intervention)
Title
Anxiety symptoms
Description
Patient-Reported Outcomes Measurement Information System-Anxiety item bank will be administered
Time Frame
At day 7 (after intervention)
Title
Anxiety symptoms
Description
Patient-Reported Outcomes Measurement Information System-Anxiety item bank will be administered
Time Frame
At day 14 (7 days after intervention)
Title
Depression symptoms
Description
Patient-Reported Outcomes Measurement Information System-Depression item bank will be administered
Time Frame
At day 7 (after intervention)
Title
Depression symptoms
Description
Patient-Reported Outcomes Measurement Information System-Depression item bank will be administered
Time Frame
At day 14 (7 days after intervention)
Title
Prescription opioid misuse
Description
Current Opioid Misuse Measure will be administered
Time Frame
At day 14 (7 days after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years Chronic pain ( > 3months) Prescription opioid use (>3 months) Exclusion Criteria: Current diagnosis of cancer Concurrent psychological therapy Other severe psychiatric conditions (schizophrenia, delusional disorder, psychotic disorder, dissociative disorder, and active suicidality) Any skin conditions on the hand (pain testing site) Non-English speaker No access to email or smart phone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tara Maronesy, BS
Phone
650-497-0857
Email
tmarones@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dokyoung S You, PhD
Phone
650-724-9320
Email
dsyou@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dokyoung S You, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNAPL
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
Nareh Megeridichian, BS
Phone
650-497-0857
Email
nmegerdi@stanford.edu
First Name & Middle Initial & Last Name & Degree
Dokyoung S You, PhD
Phone
6507249320
Email
dsyou@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Catastrophizing and Prescription Opioid Craving

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