HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain
NCT06931158 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340
Last updated 2025-04-27
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
- 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
Sponsors & Collaborators
-
Rhode Island Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2027-01-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
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