Back to resultsOptimizing Open Label Placebo Rationales
Primary Purpose
Chronic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
TAU Rationale
Mindfulness Rationale
Suspension of Disbelief Rationale
Arm Description
Rationale based on prior OLP studies (e.g. Kaptchuk et al., 2010)
Rationale based on mindfulness meditation
Rationale based on suspending disbelief about the placebo
Outcomes
Primary Outcome Measures
Pain Reports
Brief Pain Inventory: Pain intensity and pain interference
Secondary Outcome Measures
Opioids
Quantity of prescription opioids taken
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05952960
Brief Title
Optimizing Open Label Placebo Rationales
Official Title
Optimizing Open Label Placebo Rationales for Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 18, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAU Rationale
Arm Type
Other
Arm Description
Rationale based on prior OLP studies (e.g. Kaptchuk et al., 2010)
Arm Title
Mindfulness Rationale
Arm Type
Other
Arm Description
Rationale based on mindfulness meditation
Arm Title
Suspension of Disbelief Rationale
Arm Type
Other
Arm Description
Rationale based on suspending disbelief about the placebo
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Open Label Placebo + Rationale
Primary Outcome Measure Information:
Title
Pain Reports
Description
Brief Pain Inventory: Pain intensity and pain interference
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Opioids
Description
Quantity of prescription opioids taken
Time Frame
21 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Smith, BS
Phone
4014444233
Email
WSmith@lifespan.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Optimizing Open Label Placebo Rationales
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