NCT06931158

HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain

Optimizing Open Placebos for Chronic Pain Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. This study will include patients with chronic low back pain. The main question it aims to answer is: How do rationales influence the effects of open-label placebos? Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.

Conditions

• Chronic Low-back Pain
• Chronic Pain

Interventions

Type	Name	Description
DRUG	Open-label Placebo	Open-label placebo pill for 21 days at 2 per day
BEHAVIORAL	Standard Rationale	Scientific rationale about the placebo effect
BEHAVIORAL	Mindfulness	Mindfulness based rationale
BEHAVIORAL	Control Rationale	Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2025-04-17
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States