Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving
Primary Purpose
Inhalants Craving
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Essential oil
Perfume
Cue-induced inhalants craving
Sponsored by
About this trial
This is an interventional treatment trial for Inhalants Craving
Eligibility 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.
Sites / Locations
- Princess Mother National Institute on Drug Abuse Treatment
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Essential oil
Perfume
Arm Description
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.
Perfume is the synthetic perfume of lavender flavor without essential oil.
Outcomes
Primary Outcome Measures
Inhalants craving - PACS
Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)
Inhalants craving - VAS
Inhalants craving was measured by the Visual Analog Scale (VAS).
Secondary Outcome Measures
Full Information
NCT ID
NCT03296943
First Posted
September 24, 2017
Last Updated
September 26, 2017
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT03296943
Brief Title
Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2010 (Actual)
Primary Completion Date
November 30, 2010 (Actual)
Study Completion Date
November 30, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalants Craving
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Essential oil
Arm Type
Experimental
Arm Description
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.
Arm Title
Perfume
Arm Type
Sham Comparator
Arm Description
Perfume is the synthetic perfume of lavender flavor without essential oil.
Intervention Type
Combination Product
Intervention Name(s)
Essential oil
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Perfume
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cue-induced inhalants craving
Intervention Description
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 Measure Information:
Title
Inhalants craving - PACS
Description
Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)
Time Frame
Daily for 3 days
Title
Inhalants craving - VAS
Description
Inhalants craving was measured by the Visual Analog Scale (VAS).
Time Frame
Daily for 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmon Kalayasiri, M.D.
Organizational Affiliation
Chulalongkorn University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Mother National Institute on Drug Abuse Treatment
City
Pathum Thani
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving
We'll reach out to this number within 24 hrs