Pain Catastrophizing and Prescription Opioid Craving

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Behavioral: Coping Statement

• Registration Number: NCT04097743
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2021-06-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14
• Primary Completion: 2025-01-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coping statement	Coping Statement	Daily practice of pain coping statements for 7 days

Primary Outcome Measures

Name	Time	Method
craving	At day 14 (7 days after intervention)	Visual analogue scale 0-100 will be used to measure daily craving

Secondary Outcome Measures

Name	Time	Method
Cortisol	At day 14 (7 days after intervention)	Salivary cortisol will be collected at wake up, 30-min after waking up, and 9pm
Depression symptoms	At day 14 (7 days after intervention)	Patient-Reported Outcomes Measurement Information System-Depression item bank will be administered
Prescription opioid misuse	At day 14 (7 days after intervention)	Current Opioid Misuse Measure will be administered
Anxiety symptoms	At day 14 (7 days after intervention)	Patient-Reported Outcomes Measurement Information System-Anxiety item bank will be administered

Trial Locations

Locations (1)

SNAPL; 🇺🇸 Palo Alto, California, United States