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

NCT ID: NCT03296943

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-01

Study Completion Date

2010-11-30

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)

Detailed Description

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Conditions

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Inhalants Craving

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Essential oil

Intervention Type 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.

Cue-induced inhalants craving

Intervention Type 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.

Perfume

Perfume is the synthetic perfume of lavender flavor without essential oil.

Group Type SHAM_COMPARATOR

Perfume

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Rasmon Kalayasiri

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rasmon Kalayasiri, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University Faculty of Medicine

Locations

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Princess Mother National Institute on Drug Abuse Treatment

Pathum Thani, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Graduate School Grant 2553

Identifier Type: -

Identifier Source: org_study_id