Optimizing Open Label Placebo Rationales | NCT05952960

Studies
Optimizing Open Label Placebo Rationales

NCT05952960

Sponsor

Rhode Island Hospital

Status

Completed

Last Update Posted

Jul 28, 2025Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Chronic Pain

Interventions

Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

May 1, 2023

First Submission Date that Met QC Criteria

Jul 17, 2023

First Posted Date

Jul 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2025

Last Update Posted Date

Jul 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Open Label Placebo + Rationale	Mindfulness Rationale Suspension of Disbelief Rationale TAU Rationale

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital		Providence	Rhode Island	02912	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided