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

Lifespan

Status: Enrolling

Conditions: Chronic Low-back Pain; Chronic Pain

Treatments: Behavioral: Standard Rationale; Drug: Open-label Placebo; Behavioral: Mindfulness; Behavioral: Control Rationale

Study type: Interventional

Funder types: Other

Identifiers

NCT06931158

RIH-2053624-7

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 4 patient groups, including a placebo group

OLP + Standard Rationale

Experimental group

Description:

Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies.

Treatment:

Drug: Open-label Placebo

Behavioral: Standard Rationale

OLP + Mindfulness Rationale

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness

Drug: Open-label Placebo

OLP + Control Rationale

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Control Rationale

Drug: Open-label Placebo

No Treatment + Control Rationale

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Control Rationale