<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03296943</url>
  </required_header>
  <id_info>
    <org_study_id>Graduate School Grant 2553</org_study_id>
    <nct_id>NCT03296943</nct_id>
  </id_info>
  <brief_title>Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inhalants, which are neurotoxic central nervous system (CNS) suppressants, are frequently&#xD;
      abused by young adults. Unlike other CNS depressants, including alcohol and opiates, no&#xD;
      treatment is currently approved for inhalants dependence. In this report, a novel approach of&#xD;
      substitution treatment for inhalants addiction was explored in a double-blinded, randomized,&#xD;
      controlled crossover design to examine the effects of inhalation of essential oil (EO) and&#xD;
      perfume (PF) on the reduction of cue-induced craving for inhalants in a cohort of thirty-four&#xD;
      Thai males with inhalants dependence. The craving response was measured by the modified&#xD;
      version of Penn Alcohol Craving Score for Inhalants (PACS-inhalants)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2010</start_date>
  <completion_date type="Actual">November 30, 2010</completion_date>
  <primary_completion_date type="Actual">November 30, 2010</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Inhalants craving - PACS</measure>
    <time_frame>Daily for 3 days</time_frame>
    <description>Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inhalants craving - VAS</measure>
    <time_frame>Daily for 3 days</time_frame>
    <description>Inhalants craving was measured by the Visual Analog Scale (VAS).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Inhalants Craving</condition>
  <arm_group>
    <arm_group_label>Essential oil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Perfume</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Perfume is the synthetic perfume of lavender flavor without essential oil.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Essential oil</intervention_name>
    <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.</description>
    <arm_group_label>Essential oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Perfume</intervention_name>
    <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.</description>
    <arm_group_label>Perfume</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cue-induced inhalants craving</intervention_name>
    <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.</description>
    <arm_group_label>Essential oil</arm_group_label>
    <arm_group_label>Perfume</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with ability to smell if they could correctly identify 3 out of 5 odors,&#xD;
             namely fish sauce, lemon, onion, basil, and jasmine.&#xD;
&#xD;
          -  Individuals with inducible picture-cues inhalant craving based on a 50% increase in&#xD;
             craving score from baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with a history of major psychiatric disorders, including psychotic and&#xD;
             mood disorders&#xD;
&#xD;
          -  Individuals with illicit substance dependence other than inhalants&#xD;
&#xD;
          -  Individuals with allergic reactions to essential oil or perfume.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rasmon Kalayasiri, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chulalongkorn University Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Mother National Institute on Drug Abuse Treatment</name>
      <address>
        <city>Pathum Thani</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Rasmon Kalayasiri</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03296943
org study id: Graduate School Grant 2553
nct id: NCT03296943
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
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.
measure: Inhalants craving - PACS
time frame: Daily for 3 days
description: Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)
measure: Inhalants craving - VAS
time frame: Daily for 3 days
description: Inhalants craving was measured by the Visual Analog Scale (VAS).
arm group label: Essential oil
arm group type: Experimental
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 group label: Perfume
arm group type: Sham Comparator
description: Perfume is the synthetic perfume of lavender flavor without essential oil.
intervention type: Combination Product
intervention name: Essential oil
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.
arm group label: Essential oil
intervention type: Combination Product
intervention name: Perfume
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.
arm group label: Perfume
intervention type: Behavioral
intervention name: Cue-induced inhalants craving
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.
arm group label: Essential oil
arm group label: Perfume
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rasmon Kalayasiri, M.D.
role: Principal Investigator
affiliation: Chulalongkorn University Faculty of Medicine
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Rasmon Kalayasiri
investigator title: Associate Professor
mesh term: Respiratory Aspiration
sharing ipd: No