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OpenTrials
Completed

NCT Number: NCT06931158

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

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.

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Key information

Conditions

Chronic Low-back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

About this study

Further information about study design and hypothesis is provided in the following citation. Study start date refers to the date the first participant completed baseline assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open-label placebo

Drug

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

Other names: OLP, Zeebo

Standard Rationale

Behavioral

Scientific rationale about the placebo effect

Mindfulness

Behavioral

Mindfulness based rationale

Control Rationale

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain interference

    Time frame: across 42 days

    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.

  2. Pain catastrophizing

    Time frame: across 42 days

    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

  3. Prescription Medication use (including opioids)

    Time frame: across 42 days

Other outcomes

  1. Placebo use

    Time frame: across 21 days

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

Optimizing Open Placebos for Chronic Pain Patients

Acronym: HOPE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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