Clinical trial NCT03407937: The Effect of Hypnosis on Blood Concentrations of Endocannabinoids
Official title: The Role of the Endocannabinoids During the Analgesia Caused by Hypnosis and Meditation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypnosis
Endocannabinoids
Analgesia
Keywords: Hypnosis
Meditation
Conditioned pain modulation
Placebo
Endocannabinoids
Opioid peptides
Norepinephrine
Pain
Analgesia
Genes
Heart rate variability
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measures on a single group of participants
Primary purpose: BASIC_SCIENCE

Brief summary: Introduction: Many interventions such as hypnosis, mindfulness meditation, conditioned pain modulation and placebos have been shown to effectively reduce pain both in the laboratory and in clinical settings. However, little is known about their neurophysiological mechanisms of action. Analgesia induced by these techniques is thought to be based on opioidergic and non-opioidergic mechanisms (potentially endocannabinoid mechanisms). Objective: Our main objective is to evaluate the effect of hypnosis, meditation, conditioned pain modulation and placebo on blood concentrations of endocannabinoids (anandamide, 2-arachidonylglycerol, N-palmitoyl-ethanolamine, N-oleoylethanolamide), endogenous opioids (β-endorphins, met / leu-enkephalins, and dynorphins) and norepinephrine in healthy adults. Methods: This study is based on a single-group pre-experimental research design in which two experimental sessions including hypnosis or meditation, conditioned pain modulation and placebo interventions will be completed by all participants. In order to have a better description of the sociodemographic and clinical characteristics of the sample, information will be collected by questionnaires or tests filled by participants at baseline, including: age, sex, language, culture, religion, salary, menstrual cycle of women, medication (if any), mood, anxiety, pain catastrophizing, mindfulness, hypnotic susceptibility, and DNA information. Outcome measures will be collected before, during and after each intervention. The primary outcome is plasma concentrations of endocannabinoids. Secondary measurements include plasma concentrations of endogenous opioids and norepinephrine; change in pain intensity during the thermal noxious stimuli; and autonomic nervous system variability (as measured by heart rate variability). Anticipated results: The investigators expect a positive relationship between the change in pain intensity (analgesia) induced by the interventions (hypnosis, meditation, conditioned pain modulation, and placebo) and the change (increase) in plasma concentrations of endocannabinoids, opioids, and norepinephrine in healthy adults. It is also believed that the interventions will influence heart rate variability. Moreover, it is expected that there will be a relationship between the efficiency of the analgesic intervention and some gene polymorphisms associated to pain modulation and endocannabinoids, opioids or norepinephrine in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Being an healthy adult aged 18-45 years old with no prior experience of hypnosis.

Exclusion Criteria:

* Having difficulty understanding french language
* Having a vulnerability to dissociative or psychotic episodes
* Having a diagnosed medical condition or diagnosis of chronic pain leading to kidney, liver, dermatological, respiratory, hematological, immunological, cardiovascular, inflammatory, rheumatologic, endocrine, metabolic, neurological or psychiatric pathologies
* Being pregnant or breast-feeding
* Having a body mass index over 40
* Using medication, recreational drugs or other agents that affect the central nervous system or the perception of pain (e.g., analgesics, opioids, antiepileptics, muscle relaxers)

Primary outcomes:
measure: Change from baseline concentration of endocannabinoids at the end of the intervention
timeFrame: Immediately before and after each intervention
Secondary outcomes:
measure: Change from baseline concentrations of opioids at the end of the intervention
timeFrame: Immediately before and after each intervention
measure: Change from baseline concentrations of norepinephrine at the end of the intervention
timeFrame: Immediately before and after each intervention
measure: Quantitative aspect of pain
timeFrame: Immediately before and after each intervention
measure: Measure of the autonomic nervous system
timeFrame: Immediately before, during and immediately after each intervention
measure: DNA in salivary sample
timeFrame: Immediately after all the interventions have been completed, which will be during the second session after the pill has been ingested
Other outcomes:
measure: Anxiety
timeFrame: Immediately before each intervention
measure: Mood
timeFrame: Immediately after the consent form has been signed, before any intervention is performed
measure: Pain catastrophizing
timeFrame: Immediately after the consent form has been signed, before any intervention is performed
measure: Hypnotic susceptibility
timeFrame: Before the hypnosis intervention is performed, during the first session (immediately after the conditioned pain modulation intervention is completed)
measure: Hypnotic depth
timeFrame: Immediately after each hypnotic suggestions that will given during the Stanford Hypnotic Susceptibility Scale: Form A and during the hypnosis intervention
Locations:
city: Sherbrooke
country: Canada
facility: CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Serge Marchand, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke
name: Guillaume Leonard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: