Clinical trial NCT03934138: Does the Understanding of Placebo Mechanisms Compensate for the Loss of Efficacy Associated With Open Label Placebo
Official title: Does the Subject's Understanding of Underlying Placebo Mechanisms Compensate for the Loss of Efficacy Associated With the Disclosure of the Use of a Placebo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pain
Keywords: Placebo
Experimental pain
Lead sponsor: Laboratoire TIMC-IMAG
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups : Educated open label placebo And Conventional placebo

Each of the subjects will undergo the Cold Pressure text procedure under the condition of interest and a control.
Primary purpose: TREATMENT

Brief summary: The investigators are investigating whether, when given detailed information about underlying placebo mechanisms and pain, subjects will have a response similar to that of those subjected to a procedure in which they receive a conventional placebo treatment (associated with deception).

STUDY DESIGN: This is a non-inferior parallel, controlled and randomized, single blind trial.

POPULATION: The investigators will include in the study 126 subjects without known pathology. Participants will then be divided into 2 groups on a randomized basis.

METHODOLOGY: Each subject will undergo three sessions of Cold Pressure Test (CPT), a cold pain stimulation method: calibration, condition of interest (conventional placebo or educated placebo) and control. The investigators' main judgment criterion is be the difference in pain intensity experienced on the visual analog scale between the CPT control and the CPT under the condition of interest.

This study will allow the investigators to rule on the non-inferiority of an educated open label placebo compared to a conventional placebo in the context of an acute painful stimulation.


Eligibility criteria: Inclusion Criteria:

* Person affiliated to Social Security
* Informed consent, written and signed by the subject.

Exclusion Criteria:

* Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (CSP), which corresponds to all protected persons: pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure, cannot be included in clinical trials.
* Persons with a pathology against indicating the use of CPT experimentally induced pain :
* Any pathologies affecting the venous, arterial or lymphatic system
* Diabetes
* Cardiac disorders
* Asthma
* Frostbite
* Epilepsy
* Arthritis
* Lupus erythematosus
* Allergy to Cremafluid® cream
* Person with concomitant treatment that modifies sensitivity to pain, chronic or acute at the time of the experiment, such as analgesics, psychotropic drugs or anti-inflammatories.

Primary outcomes:
measure: Pain intensity: Visual Analogue Scale (VAS)
timeFrame: At the end of the CPT procedure, within 30 seconds after the removal of the hand from the CPT cold water tank.
Secondary outcomes:
measure: Anxiety respiratory frequency change
timeFrame: During the CPT procedure
measure: Anxiety blood pressure change
timeFrame: During the CPT procedure
measure: Knowledge of placebo's mechanisms
timeFrame: At the beginning and end of the CPT procedures
measure: Perception of the investigator
timeFrame: At the end of the study, when all CPT procedures have been carried out, within 10 minutes after the last immersion
measure: The Perceived Awareness of the Research Hypothesis Scale questionnaire
timeFrame: At the end of the study, when all CPT procedures have been carried out, within 10 minutes after the last immersion
Other outcomes:
measure: Blood pressure
timeFrame: About 1 minute before every CPT procedures and within 10 secondes after each CPT procedures
Locations:
city: Grenoble
country: France
facility: Leo Druart
city: Grenoble
country: France
facility: Saraeve Graham Longsworth
Study officials:
affiliation: TIMC IMAG Thémas team
name: Leo DRUART
role: PRINCIPAL_INVESTIGATOR
affiliation: TIMC IMAG Thémas team
name: SaraEve GRAHAM LONGSWORTH
role: PRINCIPAL_INVESTIGATOR
affiliation: TIMC IMAG Thémas team
name: Nicolas PINSAULT
role: STUDY_DIRECTOR
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citation: Druart L, Graham Longsworth S, Rolland C, Dolgopoloff M, Terrisse H, Bosson JL, Pinsault N. Can an Open-Label Placebo Be as Effective as a Deceptive Placebo? Methodological Considerations of a Study Protocol. Medicines (Basel). 2020 Jan 2;7(1):3. doi: 10.3390/medicines7010003.