Pain Catastrophizing and Prescription Opioid Craving

NCT04097743 | Terminated Results

• 2 other identifiers: 507711K23DA048972
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Craving

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

  At day 7 (after intervention)

• Craving

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

  At day 14 (7 days after intervention)

Secondary Outcomes (7)

• Cortisol

  At day 7 (after intervention)

• Cortisol

  At day 14 (7 days after intervention)

• Anxiety Symptoms

  At day 7 (after intervention)

• Anxiety Symptoms

  At day 14 (7 days after intervention)

• Depression Symptoms

  At day 7 (after intervention)

Study Arms (2)

Coping statement

EXPERIMENTAL

Daily practice of pain coping statements for 7 days

Behavioral: Coping Statement

Control

NO INTERVENTION

No instruction about pain coping statement.

Interventions

Coping Statement BEHAVIORAL

Daily practice of coping statement

Coping statement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford Pain Relief Innovations Lab

Palo Alto, California, 27604, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dokyoung Sophia You, PhD
• Organization: University of Oklahoma

dokyoung-you@ou.edu

9186603923

Study Officials

• Dokyoung S You, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: June 29, 2021
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: January 12, 2026
• Results First Posted: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)