NCT03950791

Single Session Class to Reduce Opioid Use in Chronic Pain

Completed NA Results posted Last updated 26 November 2024

What this trial tests

NA trial testing Pain Catastrophizing Class in Chronic Pain in 213 participants. Completed in 31 May 2024.

Timeline

23 September 2019

Primary endpoint
31 May 2024

31 May 2024

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	213
Start date	23 September 2019
Primary completion	31 May 2024
Estimated completion	31 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Pain Catastrophizing Class
• Health Education

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Stanford University

Who can join

Adults 18 to 80, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Use Primary · baseline and 3 months

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

Group	Value	95% CI
Pain Catastrophizing Class	-6.7	± 64.0
Health Education	-8.0	± 46.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected at baseline, pre-class assessment, and 3-, 6-, and 12-month follow-up assessments.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pain Catastrophizing Class

Serious: 1/108 (1%)

Deaths: 0/108

Health Education

Serious: 0/105 (0%)

Deaths: 0/105

Serious adverse events (1 terms)

Reaction	System	Pain Catastrophizing Class	Health Education
Suicidal Ideation	Psychiatric disorders	—	—

Most-reported serious reactions: Suicidal Ideation.

Data from ClinicalTrials.gov NCT03950791 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Ziadni MS, Chen AL, Winslow T, Mackey SC, et al · · 2020 · cited 6× · PMID 32532346 · DOI 10.1186/s13063-020-04415-x
2. Zoom-Delivered Empowered Relief for Chronic Pain: Observational Longitudinal Pilot Study Exploring Feasibility and Pain-Related Outcomes in Patients on Long-Term Opioids.
   Edwards KA, Dildine TC, You DS, Herrick AM, et al · · 2025 · cited 1× · PMID 40068160 · DOI 10.2196/68292
3. Single-session, virtual, pain relief skills class for adults with chronic pain on long-term opioids: A randomized controlled trial.
   Ziadni MS, Herrick A, Sturgeon JA, Salmasi V, et al · · 2026 · PMID 41990980 · DOI 10.1016/j.jpain.2026.106286