Clinical trial NCT05583240: Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY).
Official title: Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psychiatric Disorder
Benzodiazepine Withdrawal
Keywords: Essential Oil
Psychiatry
Olfaction
Anxiety
Insomnia
Lead sponsor: Etablissement Public de Santé Barthélemy Durand
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication in a population of stabilized patients with psychiatric disorder.

The main objective is to evaluate whether the olfaction of a mixture of essential oils can reduce the intake of BZRAs, prescribed if needed.

The investigators want to compare the number of medications prescribed on "if needed" basis before and after the introduction of Essential Oils.

A period prior to inclusion is used to assess the participant's frequency of BZRA use. Then, participants will received Essential Oils through a nasal stick during 4 weeks. During this period, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.

Detailed description: It is a common in psychiatry for a physician to prescribe a patient, regardless of pathology, a treatment to be taken punctually in case of anxiety, nervousness, irritability or difficulty falling asleep. This "if needed" treatment can be add to the patient's usual treatment or constitute his only drug treatment.

Most of the time, the "if needed" medication prescribed is a BZRA, which exposes the patient to the risk of creating dependency and drug abuse if the doses are multiplied.

In this context, it seems interesting to us to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication.

A two-week period prior to inclusion is used to assess the patient's frequency of BZRA use.

During the pre-inclusion visit, the investigators explain the study protocol, the patient gives consent, and they are given a diary to record their BZRA use.

(one of the inclusion criteria is more than 3 and less than 21).

At the second visit, the patient fills out the anxiety and sleep questionnaire, the investigators perform an allergy test, and they receive an aromastick.

At following visits, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.

Eligibility criteria: Inclusion Criteria:

* Adult without legal protection measures
* Ambulatory followed up
* Stabilised main psychiatric pathology
* Patient having had recourse between 3 and 21 times a week in the previous 14 days to a benzodiazepine or related treatment, for anxiolytic or hypnotic purposes, prescribed "if necessary" (on request)
* Patient who understand French both orally and in writing
* Patient who do not have an identified organic cause for their disorder
* Patient who be affiliated to a social security scheme
* Patient who have given their free and informed consent and signed the consent form

Exclusion Criteria:

* Patients with asthma or unstable epilepsy
* Pregnancy or breastfeeding
* EO allergies
* Patients having already a regular consumption of EO for the study indication
* Patients under guardianship or under reinforced guardianship

Primary outcomes:
measure: Number of medications prescribed
timeFrame: 4 weeks
Secondary outcomes:
measure: Anxiety level
timeFrame: 4 weeks
measure: Sleep level
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Étampes
country: France
facility: Etablissement Public de Santé Barthélemy Durand
Study officials:
affiliation: Etablissement Public de Santé Barthélemy Durand
name: Christian Trichard
role: PRINCIPAL_INVESTIGATOR
References: