Optimizing Open Label Placebo Rationales

NCT ID: NCT05952960

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAU Rationale

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

Group Type OTHER

Placebo

Intervention Type OTHER

Open Label Placebo + Rationale

Mindfulness Rationale

Rationale based on mindfulness meditation

Group Type OTHER

Placebo

Intervention Type OTHER

Open Label Placebo + Rationale

Suspension of Disbelief Rationale

Rationale based on suspending disbelief about the placebo

Group Type OTHER

Placebo

Intervention Type OTHER

Open Label Placebo + Rationale

Interventions

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Placebo

Open Label Placebo + Rationale

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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196178

Identifier Type: -

Identifier Source: org_study_id

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