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

NCT03296943 | Completed Phase 3

• 1 other identifier: Graduate School Grant 2553
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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)

Conditions

Inhalants Craving

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Essential oil

EXPERIMENTAL

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; Behavioral: Cue-induced inhalants craving

Perfume

SHAM COMPARATOR

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

Combination Product: Perfume; Behavioral: Cue-induced inhalants craving

Interventions

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.

Essential oil

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.

Perfume

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.

Essential oil; Perfume

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Princess Mother National Institute on Drug Abuse Treatment

Pathum Thani, Thailand

Location

MeSH Terms

Interventions

Oils, Volatile; Perfume

Intervention Hierarchy (Ancestors)

Oils; Lipids; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Rasmon Kalayasiri, M.D.

  Chulalongkorn University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2017
• First Posted: September 29, 2017
• Study Start: July 1, 2010
• Primary Completion: November 30, 2010
• Study Completion: November 30, 2010
• Last Updated: September 29, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)