Optimizing Open Label Placebo Rationales

Optimizing Open Label Placebo Rationales for Chronic Pain

A 3-arm randomized trial where all chronic pain patients will receive honest placebos, but the information about the placebos will differ between conditions. Outcomes are measured for 21 days and a qualitative survey will be conducted.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• chronic pain
• 18 years old
• English speaking
• have a smartphone or computer with video access
• Taking prescription opioids for chronic pain
• the chronic pain is concentrated into the patient's lower back.

Exclusion Criteria:

• suspect an allergy to any placebo ingredient
• problematic substance use
• cancer diagnosis causing pain
• anticipated change in opioid script during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TAU Rationale; Rationale based on prior OLP studies (e.g. Kaptchuk et al., 2010)	Other: Placebo; Open Label Placebo + Rationale
Other: Mindfulness Rationale; Rationale based on mindfulness meditation	Other: Placebo; Open Label Placebo + Rationale
Other: Suspension of Disbelief Rationale; Rationale based on suspending disbelief about the placebo	Other: Placebo; Open Label Placebo + Rationale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Reports	Brief Pain Inventory: Pain intensity and pain interference	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioids	Quantity of prescription opioids taken	21 Days

Collaborators and Investigators

• Sponsor: Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 196178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No