Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving

Study Overview
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Brief Summary
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Inhalants, which are neurotoxic central nervous system (CNS) suppressants, are frequently abused by young adults. Unlike other CNS depressants, including alcohol and opiates, no treatment is currently approved for inhalants dependence. In this report, a novel approach of substitution treatment for inhalants addiction was explored in a double-blinded, randomized, controlled crossover design to examine the effects of inhalation of essential oil (EO) and perfume (PF) on the reduction of cue-induced craving for inhalants in a cohort of thirty-four Thai males with inhalants dependence. The craving response was measured by the modified version of Penn Alcohol Craving Score for Inhalants (PACS-inhalants)

Official Title
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A Novel Approach of Substitution Therapy With Inhalation of Essential Oil for the Reduction of Inhalants Craving: A Double-blinded Randomized Controlled Trial

Conditions
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Inhalants Craving

Intervention / Treatment
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* Combination Product: Essential oil
* Combination Product: Perfume
* Behavioral: Cue-induced inhalants craving


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with ability to smell if they could correctly identify 3 out of 5 odors, namely fish sauce, lemon, onion, basil, and jasmine. Individuals with inducible picture-cues inhalant craving based on a 50% increase in craving score from baseline. Exclusion Criteria: Individuals with a history of major psychiatric disorders, including psychotic and mood disorders Individuals with illicit substance dependence other than inhalants Individuals with allergic reactions to essential oil or perfume.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Essential oil<br>Essential oil is prepared from the product of Thailada with manufacture standard ID 1087/2548 by Thailand Ministry of Industry. Essential oil is extracted by a cold compressed method from the lavandula angustifolia (lavender) grown in Australia. | Combination Product: Essential oil<br>* To inhale the essential oil in an air-conditioned room, the container was flipped over to soak the roll-on cap that was then rolled-on circularly at the right mid-palm of the subject at 2 centimeter in diameter for 5 cycles.<br>Behavioral: Cue-induced inhalants craving<br>* Exposing individuals with a set of 12 pictures for one-minute (e.g., 5 second display per picture) every five minutes for three sets in total followed by another three sets of neutral/relaxing pictures of nature.<br>|
| Sham Comparator: Perfume<br>Perfume is the synthetic perfume of lavender flavor without essential oil. | Combination Product: Perfume<br>* To inhale the perfume in an air-conditioned room, the container was flipped over to soak the roll-on cap that was then rolled-on circularly at the right mid-palm of the subject at 2 centimeter in diameter for 5 cycles.<br>Behavioral: Cue-induced inhalants craving<br>* Exposing individuals with a set of 12 pictures for one-minute (e.g., 5 second display per picture) every five minutes for three sets in total followed by another three sets of neutral/relaxing pictures of nature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhalants craving - PACS | Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants) | Daily for 3 days | 
| Inhalants craving - VAS | Inhalants craving was measured by the Visual Analog Scale (VAS). | Daily for 3 days |