Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY).

Psychiatric Disorder Clinical Trial

— 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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583240
• Other study ID #: 21P01
• Secondary ID: 2019-A02345-52
• Status: Recruiting
• Phase: Phase 4
• Start date: April 19, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: October 2022
• Source: Etablissement Public de Santé Barthélemy Durand
• Contact: Adelaide Aduayi
• Phone: +33 1 75 02 16 81
• Email: adelaide.aduayi[@]eps-etampes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 30, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Benzodiazepine Withdrawal
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Drug:
• Essences and Essential Oils
Participants will received Essential Oils through a nasal stick during 4 weeks.

Locations

Country	Name	City	State
France	Etablissement Public de Santé Barthélemy Durand	Étampes

Sponsors (1)

Lead Sponsor	Collaborator
Etablissement Public de Santé Barthélemy Durand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of medications prescribed	Compare the number of medications prescribed on "if needed" basis before and after the introduction of essential oils.	4 weeks
Secondary	Anxiety level	STAI (State Trait Anxiety Inventory) scale	4 weeks
Secondary	Sleep level	Pittsburgh Sleep Quality Index (PSQI) scale	4 weeks