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

NCT ID: NCT06931158

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low-back Pain Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants are blind to the research hypothesis but not to treatment allocation that are by definition open.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Open-label Placebo

Intervention Type DRUG

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

Standard Rationale

Intervention Type BEHAVIORAL

Scientific rationale about the placebo effect

OLP + Mindfulness Rationale

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

Group Type EXPERIMENTAL

Open-label Placebo

Intervention Type DRUG

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

Mindfulness

Intervention Type BEHAVIORAL

Mindfulness based rationale

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.

Group Type PLACEBO_COMPARATOR

Open-label Placebo

Intervention Type DRUG

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

Control Rationale

Intervention Type BEHAVIORAL

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

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.

Group Type SHAM_COMPARATOR

Control Rationale

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Open-label Placebo

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

Intervention Type DRUG

Standard Rationale

Scientific rationale about the placebo effect

Intervention Type BEHAVIORAL

Mindfulness

Mindfulness based rationale

Intervention Type BEHAVIORAL

Control Rationale

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OLP Zeebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Bernstein

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Study Coordination

Role: CONTACT

401-606-4766

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

HOPE Study

Role: primary

401-606-4766

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RIH-2053624-7

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of Pain Relief in Low Back Pain
NCT00325949 COMPLETED PHASE3