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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03296943
Other study ID # Graduate School Grant 2553
Secondary ID
Status Completed
Phase Phase 3
First received September 24, 2017
Last updated September 26, 2017
Start date July 1, 2010
Est. completion date November 30, 2010

Study information

Verified date September 2017
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date November 30, 2010
Est. primary completion date November 30, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Thailand Princess Mother National Institute on Drug Abuse Treatment Pathum Thani

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inhalants craving - PACS Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants) Daily for 3 days
Primary Inhalants craving - VAS Inhalants craving was measured by the Visual Analog Scale (VAS). Daily for 3 days