NCT06931158 · Rhode Island Hospital
HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain
(HOPE)
What this study is about
The goal of this clinical trial is to examine the effect of rationale condition when taking where both patients and doctors know the treatment given 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.
View original scientific description
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.
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
Primary outcome measures
Pain intensity
Time frame: across 42 days
Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over)
- at least 18 years old
- English speaking
- have a smartphone or computer with video access
- the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate)
Exclusion criteria
- Have chronic pain because of a cancer diagnosis
- Over 89 years of age
- Suspect an allergy to any placebo ingredient
- Currently receiving worker's compensation.
Where
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2025 · Source of record for eligibility and locations