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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT06931158
Status
Recruiting
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Conditions

  • Chronic Low-back Pain
  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Open-label Placebo — DRUG
    Open-label placebo pill for 21 days at 2 per day
  • 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

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Apr 2025
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Experimental: OLP + Mindfulness Rationale
    Participants in this group will receive an open-label placebo along with information with mindfulness information.
  • 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.
  • 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.

Primary Outcome Measure

Pain intensity [ Time Frame: across 42 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02906
HOPE Study
[email protected]
401-606-4766

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By research site
Rhode Island Hospital· Providence, RI

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