NCT05952960

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

May 1, 2023

Last Update Submit

July 23, 2025

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Reports

    Brief Pain Inventory: Pain intensity and pain interference

    21 days

Secondary Outcomes (1)

  • Opioids

    21 Days

Study Arms (3)

TAU Rationale

OTHER

Rationale based on prior OLP studies (e.g. Kaptchuk et al., 2010)

Other: Placebo

Mindfulness Rationale

OTHER

Rationale based on mindfulness meditation

Other: Placebo

Suspension of Disbelief Rationale

OTHER

Rationale based on suspending disbelief about the placebo

Other: Placebo

Interventions

PlaceboOTHER

Open Label Placebo + Rationale

Mindfulness RationaleSuspension of Disbelief RationaleTAU Rationale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic pain
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2023

First Posted

July 19, 2023

Study Start

July 15, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations

US(1)