NCT02578420

Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.

Detailed description

The current project will consist of one experimental study and one qualitative study: 1. the effects of open-label, and deceptive placebo administration on placebo analgesia will be directly compared when both groups have a comparable expectancy-inducing scientific rationale; 2. subjective meaning models will be assessed by comparing subjective narratives of the placebo effect in open-label and deceptive placebo groups in a nested qualitative study. The experimental study will be a randomized experiment with healthy subjects (N=120), and pain will be induced using a standardized heat pain paradigm (Medoc, Ramatishai, Israel; thermo-sensory analyzer (TSA)-II). Effects of the experimental conditions will be assessed both objectively (i.e. heat pain threshold and tolerance) and subjectively (i.e. subjective pain ratings, pain intensity and unpleasantness). Furthermore, investigators will randomly select 30 participants to take part in a nested qualitative study in order to qualitatively assess the meaning response by comparing subjective narratives of the placebo effect in the open-label and deceptive placebo groups, as well as in the control group.

Conditions

• Placebo Effect
• Pain
• Expectancy

Interventions

Type	Name	Description
OTHER	open-label placebo	Placebo Cream, openly described as "Placebo"
OTHER	deceptive placebo	Placebo Cream, described as "Voltaren, containing Diclofenac"

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-07-01
• Completion: 2017-06-01
• First posted: 2015-10-19
• Last updated: 2017-07-26

Locations

1 site across 1 country: Switzerland