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

Optimizing Open Placebos for Chronic Pain Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Chronic Low-back Pain
• Intervention / Treatment: Drug: Open-label Placebo; Behavioral: Standard Rationale; Behavioral: Mindfulness; Behavioral: Control Rationale

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordination; Phone Number: 401-606-4766; Email: HOPE-trial@lifespan.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • Rhode Island Hospital
      • Contact: HOPE Study; Phone Number: 401-606-4766; Email: HOPE-trial@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria are:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OLP + Standard Rationale; Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies.	Drug: Open-label Placebo; Open-label placebo pill for 21 days at 2 per day; Other Names: Zeebo; OLP; Behavioral: Standard Rationale; Scientific rationale about the placebo effect
Experimental: OLP + Mindfulness Rationale; Participants in this group will receive an open-label placebo along with information with mindfulness information.	Drug: Open-label Placebo; Open-label placebo pill for 21 days at 2 per day; Other Names: Zeebo; OLP; Behavioral: Mindfulness; Mindfulness based rationale
Placebo Comparator: OLP + Control Rationale; Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.	Drug: Open-label Placebo; Open-label placebo pill for 21 days at 2 per day; Other Names: Zeebo; OLP; Behavioral: Control Rationale; Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
Sham Comparator: No Treatment + Control Rationale; Participants in this group will receive no treatment. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design.	Behavioral: Control Rationale; Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity	across 42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription Medication use (including opioids)		across 42 days
Pain interference	Pain Interference subscale from Brief Pain Inventory Pain interference is measured for general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life on a 0-10 NRS with 0 = "does not interfere" and 10 = "completely interferes" Higher scores indicated greater pain intensity or greater interference with function.	across 42 days
Pain catastrophizing	Single item assessing how much the patient catastrophizes about their pain from 0 (minimum) to 10 (maximum). Higher scores indicate more catastrophizing. 13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time Higher score indicates higher level of catastrophizing Item scores are summed into a total score (PCS-T) and three subscale scores: Rumination (PCS-R): Items 8, 9, 10, and 11; Magnification (PCS-M): Items 6, 7, 13; Helplessness (PCS-H): Items 1, 2, 3, 4, 5, and 12 Minimum total score = 0, maximum total score = 52 Subscale score ranges: PCS-R: 0-16; PCS-M: 0-12; PCS-H: 0-24 A total score above 30 indicates clinically relevant level of catastrophizing	across 42 days

Other Outcome Measures

Outcome Measure	Time Frame
Placebo use	across 21 days

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: placebo effect; open-label placebo; rationales
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Chronic Pain; Low Back Pain
• Other Study ID Numbers: RIH-2053624-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No