Single Session Class to Reduce Opioid Use in Chronic Pain

NCT03950791 | Completed Results DMC

• 2 other identifiers: 48784K23DA047473
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

Prescription opioids are one of the most commonly used treatments for chronic pain, despite limited evidence of their efficacy and high morbidity and mortality risks. The study aims to determine the efficacy of a targeted single-session psychology class in reducing opioid use among patients with chronic pain. The information gained from this study has the potential to identify patients who achieve a meaningful reduction in opioid use and inform opioid reduction strategies.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Opioid Use

  Clinically minimal reduction is defined as \>15% reduction in opioid use (MEDD, which is the recommended unit of measurement in studies of opioid use)

  baseline and 3 months

Study Arms (2)

Pain Catastrophizing Class

EXPERIMENTAL

A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials.

Behavioral: Pain Catastrophizing Class

Health Education

PLACEBO COMPARATOR

A 2-hour in-person informational session about general health education. Participants receive a list of resources in the community.

Behavioral: Health Education

Interventions

Pain Catastrophizing Class BEHAVIORAL

A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. It will also include mind-body science as it relates to pain and PC. Participants learn how to identify catastrophizing in the moment, and how to self-treat it. During the class, participants acquire skills and develop a plan to apply the learned skills to decrease physiological hyperarousal within the context of PC. Participants also acquire skills that improve the regulation of cognition and emotion, including PC reframing and thought restructuring, and develop a plan for implementing these skills in daily life. Finally, participants develop a plan to use behaviors that modulate attention and counteract helplessness.

Pain Catastrophizing Class

Health Education BEHAVIORAL

Education about improving lifestyle factors to improve participants' overall health.

Health Education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Diagnosis of chronic non-cancer pain (\> 3 months in duration)
• Currently using prescription opioids ≥ 10mg morphine equivalent daily dose (MEDD) for ≥ 3 months;
• Ability and willingness to complete study procedures.

You may not qualify if:

• Open litigation regarding a medical condition
• Inability to provide informed consent and complete study procedures
• Previous experience with cognitive behavioral therapy (CBT)
• Active suicidality.

Sponsors & Collaborators

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

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Ziadni MS, Chen AL, Winslow T, Mackey SC, Darnall BD. Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):521. doi: 10.1186/s13063-020-04415-x.

  PMID: 32532346 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Maisa Ziadni, PhD
• Organization: Stanford University School of Medicine

mzaidni@stanford.edu

(650) 724-9143

Study Officials

• Maisa Ziadni, 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 Instructor

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 15, 2019
• Study Start: September 23, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)