Completed

NCT Number: NCT03296943

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

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)

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Key information

Conditions

Inhalants Craving

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Princess Mother National Institute on Drug Abuse Treatment

Pathum Thani, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Essential oil

Combination Product

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.

Perfume

Combination Product

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.

Cue-induced inhalants craving

Behavioral

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.

Primary outcomes

Inhalants craving - PACS

Time frame: Daily for 3 days

Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)
Inhalants craving - VAS

Time frame: Daily for 3 days

Inhalants craving was measured by the Visual Analog Scale (VAS).

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Sep 29, 2017
Registry last updated: Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.