Skip to main content
Clinical Trials/NCT04097743
NCT04097743
Terminated
Not Applicable

Effect of Pain Catastrophizing on Prescription Opioid Craving

Stanford University1 site in 1 country93 target enrollmentJune 29, 2021
ConditionsChronic Pain
InterventionsCoping Statement

Overview

Phase
Not Applicable
Intervention
Coping Statement
Conditions
Chronic Pain
Sponsor
Stanford University
Enrollment
93
Locations
1
Primary Endpoint
Craving
Status
Terminated
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 29, 2021
End Date
December 10, 2024
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dokyoung Sophia You

Clinical Assistant Professor

Stanford University

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

Arms & Interventions

Coping statement

Daily practice of pain coping statements for 7 days

Intervention: Coping Statement

Control

No instruction about pain coping statement.

Outcomes

Primary Outcomes

Craving

Time Frame: At day 14 (7 days after intervention)

Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.

Craving

Time Frame: At day 7 (after intervention)

Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.

Secondary Outcomes

  • Cortisol(At day 14 (7 days after intervention))
  • Anxiety Symptoms(At day 14 (7 days after intervention))
  • Depression Symptoms(At day 14 (7 days after intervention))
  • Prescription Opioid Misuse(At day 14 (7 days after intervention))
  • Cortisol(At day 7 (after intervention))
  • Anxiety Symptoms(At day 7 (after intervention))
  • Depression Symptoms(At day 7 (after intervention))

Study Sites (1)

Loading locations...

Similar Trials