Inhalants CravingPhase 3NCT03296943
Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving
A Phase 3 study testing Essential oil, Perfume and Cue-induced inhalants craving in people with Inhalants Craving, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inhalants Craving
- What is being tested?
- Essential oil, Perfume and Cue-induced inhalants craving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2010to 30 Nov 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Princess Mother National Institute on Drug Abuse Treatment
Pathum Thani
About this study
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
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
- Being tested
- Essential oil, Perfume, Cue-induced inhalants craving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential oilCombination 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.
PerfumeCombination 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 cravingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Essential oil; Behavioral: Cue-induced inhalants craving |
| Perfume | Sham comparator | Perfume is the synthetic perfume of lavender flavor without essential oil. Receives: Combination Product: Perfume; Behavioral: Cue-induced inhalants craving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhalants craving - PACS
Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)
Measured: Daily for 3 days
Inhalants craving - VAS
Inhalants craving was measured by the Visual Analog Scale (VAS).
Measured: Daily for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Jul 2010
- Primary completion30 Nov 2010
- Study completion30 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalants CravingStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmon Kalayasiri, Chulalongkorn University
- Investigators
- Rasmon Kalayasiri, M.D., Principal investigator, Chulalongkorn University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296943
- Sponsor's protocol ID
- Graduate School Grant 2553
- Status last verified
- Sep 2017
- First submitted
- 24 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03296943
- Acronym / sponsor ID
- Graduate School Grant 2553
- Conditions
- Inhalants Craving
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 30 Nov 2010 (actual)
- Study completion
- 30 Nov 2010 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential oil | Experimental | Combination Product: Essential oil, Behavioral: Cue-induced inhalants cravingEssential 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 | Sham comparator | Combination Product: Perfume, Behavioral: Cue-induced inhalants cravingPerfume is the synthetic perfume of lavender flavor without essential oil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential oilTo 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. | Combination product | Essential oil |
| PerfumeTo 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. | Combination product | Perfume |
| Cue-induced inhalants cravingExposing 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. | Behavioural | Essential oil, Perfume |
Primary outcome
Inhalants craving - PACS
Time frame: Daily for 3 days
Inhalants craving was measured by the Penn Alcohol Craving Scale for Inhalants (PACS-inhalants)
Inhalants craving - VAS
Time frame: Daily for 3 days
Inhalants craving was measured by the Visual Analog Scale (VAS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasmon Kalayasiri, M.D. principal investigator
Chulalongkorn University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Essential oil, Perfume and Cue-induced inhalants craving in people with Inhalants Craving, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhalants craving - PACS (time frame: Daily for 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.