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

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ClinicalTrials.gov Identifier: NCT03296943
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Rasmon Kalayasiri, Chulalongkorn University

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Inhalants Craving Combination Product: Essential oil Combination Product: Perfume Behavioral: Cue-induced inhalants craving Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The containers for essential oil and perfume are identical dark-glass tubes with a roll-on-cap on top and double-covered with a plain cap on each tube.
Primary Purpose: Treatment
Official Title: A Novel Approach of Substitution Therapy With Inhalation of Essential Oil for the Reduction of Inhalants Craving: A Double-blinded Randomized Controlled Trial
Actual Study Start Date : July 1, 2010
Actual Primary Completion Date : November 30, 2010
Actual Study Completion Date : November 30, 2010

Arm Intervention/treatment
Experimental: Essential oil
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
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.

Behavioral: Cue-induced inhalants craving
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.

Sham Comparator: Perfume
Perfume is the synthetic perfume of lavender flavor without essential oil.
Combination Product: Perfume
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.

Behavioral: Cue-induced inhalants craving
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 Outcome Measures :
  1. Inhalants craving - PACS [ Time Frame: Daily for 3 days ]
    Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)

  2. Inhalants craving - VAS [ Time Frame: Daily for 3 days ]
    Inhalants craving was measured by the Visual Analog Scale (VAS).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296943


Locations
Thailand
Princess Mother National Institute on Drug Abuse Treatment
Pathum Thani, Thailand
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Rasmon Kalayasiri, M.D. Chulalongkorn University Faculty of Medicine

Responsible Party: Rasmon Kalayasiri, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03296943     History of Changes
Other Study ID Numbers: Graduate School Grant 2553
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No