Optimizing Open Label Placebo Rationales

Sponsor

Rhode Island Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05952960

Collaborator

(none)

Enrollment

Arms

5.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Optimizing Open Label Placebo Rationales for Chronic Pain

Anticipated Study Start Date :

Jul 18, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain Reports [21 days]
Brief Pain Inventory: Pain intensity and pain interference

Secondary Outcome Measures

Opioids [21 Days]
Quantity of prescription opioids taken

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rhode Island Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rhode Island Hospital

ClinicalTrials.gov Identifier:

NCT05952960

Other Study ID Numbers:

196178

First Posted:

Jul 19, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Jul 19, 2023