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NCT05952960 Clinical Trial

Optimizing Open Label Placebo Rationales

Chronic Pain Clinical Trial

Official title:
Optimizing Open Label Placebo Rationales for Chronic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05952960
Other study ID # 196178
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 18, 2023
Est. completion date December 30, 2023

Study information
Verified date May 2023
Source Rhode Island Hospital
Contact Wendy Smith, BS
Phone 4014444233
Email WSmith@lifespan.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 30, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Placebo
Open Label Placebo + Rationale

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rhode Island Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Reports Brief Pain Inventory: Pain intensity and pain interference 21 days
Secondary Opioids Quantity of prescription opioids taken 21 Days
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