Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain Catastrophizing and Prescription Opioid Craving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097743
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Dokyoung Sophia You, 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 will be potential mediators of the treatment effect.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Coping Statement Not Applicable

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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pain Catastrophizing on Prescription Opioid Craving
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Coping statement
Daily practice of pain coping statements for 7 days
Behavioral: Coping Statement
Daily practice of coping statement

No Intervention: Control
No instruction about pain coping statement.



Primary Outcome Measures :
  1. craving [ Time Frame: At day 7 (after intervention) ]
    Visual analogue scale 0-100 will be used to measure daily craving

  2. craving [ Time Frame: At day 14 (7 days after intervention) ]
    Visual analogue scale 0-100 will be used to measure daily craving


Secondary Outcome Measures :
  1. Cortisol [ Time Frame: At day 7 (after intervention) ]
    Salivary cortisol will be collected at wake up, 30-min after waking up, and 9pm

  2. Cortisol [ Time Frame: At day 14 (7 days after intervention) ]
    Salivary cortisol will be collected at wake up, 30-min after waking up, and 9pm

  3. Anxiety symptoms [ Time Frame: At day 7 (after intervention) ]
    Patient-Reported Outcomes Measurement Information System-Anxiety item bank will be administered

  4. Anxiety symptoms [ Time Frame: At day 14 (7 days after intervention) ]
    Patient-Reported Outcomes Measurement Information System-Anxiety item bank will be administered

  5. Depression symptoms [ Time Frame: At day 7 (after intervention) ]
    Patient-Reported Outcomes Measurement Information System-Depression item bank will be administered

  6. Depression symptoms [ Time Frame: At day 14 (7 days after intervention) ]
    Patient-Reported Outcomes Measurement Information System-Depression item bank will be administered

  7. Prescription opioid misuse [ Time Frame: At day 14 (7 days after intervention) ]
    Current Opioid Misuse Measure will be administered



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097743


Contacts
Layout table for location contacts
Contact: SNAPL lab 650-723-8346 dsyou@stanford.edu
Contact: Dokyoung S You, PhD 650-724-9320 dsyou@stanford.edu

Sponsors and Collaborators
Stanford University
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Dokyoung S You, PhD Stanford University

Layout table for additonal information
Responsible Party: Dokyoung Sophia You, Fellow, Stanford University
ClinicalTrials.gov Identifier: NCT04097743     History of Changes
Other Study ID Numbers: 50771
1K23DA048972 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms