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

NCT06931158 | Recruiting

• 1 other identifier: RIH-2053624-7
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

open-label placebo; rationales; placebo effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain interference

  across 42 days

• Pain catastrophizing

  across 42 days

• Prescription Medication use (including opioids)

  across 42 days

Other Outcomes (1)

• Placebo use

  across 21 days

Study Arms (4)

OLP + Standard Rationale

EXPERIMENTAL

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; Behavioral: Standard Rationale

OLP + Mindfulness Rationale

EXPERIMENTAL

Participants in this group will receive an open-label placebo along with information with mindfulness information.

Drug: Open-label Placebo; Behavioral: Mindfulness

OLP + Control Rationale

PLACEBO COMPARATOR

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; Behavioral: Control Rationale

No Treatment + Control Rationale

SHAM COMPARATOR

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

Interventions

Open-label Placebo DRUG

Open-label placebo pill for 21 days at 2 per day

Also known as: OLP, Zeebo

OLP + Control Rationale; OLP + Mindfulness Rationale; OLP + Standard Rationale

Standard Rationale BEHAVIORAL

Scientific rationale about the placebo effect

OLP + Standard Rationale

Mindfulness BEHAVIORAL

Mindfulness based rationale

OLP + Mindfulness Rationale

Control Rationale BEHAVIORAL

Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups

No Treatment + Control Rationale; OLP + Control Rationale

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Study Coordination

CONTACT

401-606-4766; HOPE-trial@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are blind to the research hypothesis but not to treatment allocation that are by definition open.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 17, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)