Opiate AbuseNCT05384470
Detecting Drugs of Abuse Via Exhaled Breath Samples Using Differential Mobility Spectrometry
An observational study of Opiate Abuse and Marijuana Abuse, run by Mclean Hospital at 1 site in United States.
Trial summary
This Phase II STTR program consists of two major goals within the overarching goal of developing and validating a proprietary device (BID2) for marijuana and opioid detection in breath samples. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Opiate Abuse, Marijuana Abuse, Diagnostic
- What is being tested?
- Marihuana and BID2 Instrument - breathalyzer
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 15 Aug 2024
- Phase
- Observational
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult male and female volunteers
Who may be able to join
- Capable of understanding and complying with the protocol
- In good physical and mental health (normal physical exam, ECG, blood and urine chemistries
- Absence of history or laboratory evidence of diabetes)
- Body Mass Index between 18-30,
- Inclusive Age 21-50 years (age will be verified by driver's license or other valid form of identification)
- Have a stable living situation with current postal address.
Who cannot join
- Meets criteria for current alcohol or substance use disorders (Past alcohol or substance use disorders greater than 3 years ago is acceptable)
- Concurrent diagnosis of Axis 1 disorder be maintained on an antipsychotic or antidepressant medication
- Taking prescription medications except certain short-term anti-fungal agents and some topical creams for dermal condition
- Heavy alcohol drinkers (greater than 15 drinks per week)
- Tobacco use greater than 5 cigarettes per day
- History of major head trauma resulting in cognitive impairment or history of seizure disorder
Show all 9Show fewer
- Heavy caffeine use (greater than 500 mg on a regular daily basis)
- Has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT)> 3x the upper limit of normal
- For female participants, a positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
This Phase II STTR program consists of two major goals within the overarching goal of developing and validating a proprietary device (BID2) for marijuana and opioid detection in breath samples.
Read the detailed description
This study is intended to lead to the development and demonstration of a breathalyzer instrument capable of detecting and quantitatively measuring drugs (i.e. cannabinoids and opioids) in exhaled breath (EB). Prior work on the detection of these drugs in EB by means of liquid chromatography and mass spectrometry (LC/MS) demonstrated that these compounds can be quantitatively detected, but LC/MS is slow, expensive and requires highly skilled personnel to implement. What is needed is a simple and inexpensive method for rapidly measuring the amount of drugs in EB.
If such a method becomes available it can be used by law enforcement and in doctors' offices, hospital emergency rooms, ambulances and other government agencies, military bases and companies seeking to screen employees for drug abuse. Vox Biomedical proposes to develop a method for quantitatively detecting the presence of drugs in EB by means of Differential Mobility Spectrometry (DMS) developed at Draper Laboratories. DMS is a robust, datarich, ultra-trace, chemical detection technology that has been proven for numerous applications including air quality cabin monitoring on the International Space Station (ISS), chemical warfare agent detection, explosives detection, and drinking water analysis. Recently Draper has applied this device to breath analysis for the detection of lung diseases.
A clinical study is currently underway and initial results are promising. This project involves transferring this technology developed by Draper for lung infection detection to the detection of psychoactive drugs in exhaled breath. Phase I of the proposed program will investigate the DMS signatures of cannabinoids in the laboratory and defining the device's limits of detection. A small pilot study will also be performed to demonstrate feasibility for using breath analysis as a proxy for the concentration of cannabinoids in the blood.
- Conditions
- Opiate Abuse, Marijuana Abuse, Diagnostic
- Being tested
- Marihuana, BID2 Instrument - breathalyzer
- Keywords
- THC, marihuana, pharmacokinetics, breathalyzer
- Medical subject headings
- Opioid-Related Disorders, Marijuana Abuse, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarihuanaDrug
Two doses of marijuana given.
BID2 Instrument - breathalyzerDevice
The commercial device that we will be testing is designed to detect breath cannabinoid concentrations utilizing Differential Mobility Spectrometry technology, and was developed by Draper, to detect a wide range of chemicals and organisms in breath. Differential Mobility Spectrometry (DMS) is a robust, data-rich, ultra-trace, chemical detection technology. Unlike gas chromatography mass spectroscopy (GCMS) systems that are large and expensive, DMS is small, portable (approximately the size of a shoe box) and is able to measure the presence of volatile organic compounds (VOC) at parts per trillion (ppt) detection levels. The participant will exhale into the device via a plastic tube and the breath sample will be analyzed in situ. The participant does not come in contact with the device itself-they will simply exhale into a tube via a disposable mouthpiece.
| Study group | Role | What they receive |
|---|---|---|
| Exhaled Breath Samples | Quantitative detection of marijuana, morphine or fentanyl through exhaled breath Receives: Drug: Marihuana; Device: BID2 Instrument - breathalyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath/cannabinoids concentrations
Quantitatively measuring cannabinoids in exhaled breath
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Aug 2021
- Primary completion19 Mar 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate AbuseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- VOX BIOMEDICAL LLC
- Responsible party
- Principal investigator, Scott Lukas, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384470
- Sponsor's protocol ID
- 2019P001633
- Other IDs
- 5R42DA049655-04
- Status last verified
- Apr 2025
- First submitted
- 16 May 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Drugs of Abuse Via Exhaled Breath Samples Using Differential Mobility Spectrometry
- ClinicalTrials.gov ID
- NCT05384470
- Acronym / sponsor ID
- 2019P001633
- Conditions
- Opiate Abuse, Marijuana Abuse, Diagnostic
- Keywords
- THC, marihuana, pharmacokinetics, breathalyzer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- VOX BIOMEDICAL LLC
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 20 May 2022 (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.
This Phase II STTR program consists of two major goals within the overarching goal of developing and validating a proprietary device (BID2) for marijuana and opioid detection in breath samples.
Detailed description
This study is intended to lead to the development and demonstration of a breathalyzer instrument capable of detecting and quantitatively measuring drugs (i.e. cannabinoids and opioids) in exhaled breath (EB). Prior work on the detection of these drugs in EB by means of liquid chromatography and mass spectrometry (LC/MS) demonstrated that these compounds can be quantitatively detected, but LC/MS is slow, expensive and requires highly skilled personnel to implement. What is needed is a simple and inexpensive method for rapidly measuring the amount of drugs in EB.
If such a method becomes available it can be used by law enforcement and in doctors' offices, hospital emergency rooms, ambulances and other government agencies, military bases and companies seeking to screen employees for drug abuse. Vox Biomedical proposes to develop a method for quantitatively detecting the presence of drugs in EB by means of Differential Mobility Spectrometry (DMS) developed at Draper Laboratories. DMS is a robust, datarich, ultra-trace, chemical detection technology that has been proven for numerous applications including air quality cabin monitoring on the International Space Station (ISS), chemical warfare agent detection, explosives detection, and drinking water analysis. Recently Draper has applied this device to breath analysis for the detection of lung diseases.
A clinical study is currently underway and initial results are promising. This project involves transferring this technology developed by Draper for lung infection detection to the detection of psychoactive drugs in exhaled breath. Phase I of the proposed program will investigate the DMS signatures of cannabinoids in the laboratory and defining the device's limits of detection. A small pilot study will also be performed to demonstrate feasibility for using breath analysis as a proxy for the concentration of cannabinoids in the blood.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exhaled Breath Samples | – | Drug: Marihuana, Device: BID2 Instrument - breathalyzerQuantitative detection of marijuana, morphine or fentanyl through exhaled breath |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult male and female volunteers
Key inclusion criteria (6 listed)
- Capable of understanding and complying with the protocol
- In good physical and mental health (normal physical exam, ECG, blood and urine chemistries
- Absence of history or laboratory evidence of diabetes)
- Body Mass Index between 18-30,
- Inclusive Age 21-50 years (age will be verified by driver's license or other valid form of identification)
Key exclusion criteria (9 listed)
- Meets criteria for current alcohol or substance use disorders (Past alcohol or substance use disorders greater than 3 years ago is acceptable)
- Concurrent diagnosis of Axis 1 disorder be maintained on an antipsychotic or antidepressant medication
- Taking prescription medications except certain short-term anti-fungal agents and some topical creams for dermal condition
- Heavy alcohol drinkers (greater than 15 drinks per week)
- Tobacco use greater than 5 cigarettes per day
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 |
|---|---|---|
| MarihuanaTwo doses of marijuana given. | Drug | Exhaled Breath Samples |
| BID2 Instrument - breathalyzerThe commercial device that we will be testing is designed to detect breath cannabinoid concentrations utilizing Differential Mobility Spectrometry technology, and was developed by Draper, to detect a wide range of chemicals and organisms in breath. Differential Mobility Spectrometry (DMS) is a robust, data-rich, ultra-trace, chemical detection technology. Unlike gas chromatography mass spectroscopy (GCMS) systems that are large and expensive, DMS is small, portable (approximately the size of a shoe box) and is able to measure the presence of volatile organic compounds (VOC) at parts per trillion (ppt) detection levels. The participant will exhale into the device via a plastic tube and the breath sample will be analyzed in situ. The participant does not come in contact with the device itself-they will simply exhale into a tube via a disposable mouthpiece. | Device | Exhaled Breath Samples |
Primary outcome
Breath/cannabinoids concentrations
Time frame: 1 year
Quantitatively measuring cannabinoids in exhaled breath
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 2 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiate Abuse and Marijuana Abuse, run by Mclean Hospital at 1 site in United States.
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 6 inclusion and 9 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 2 May 2025. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Breath/cannabinoids concentrations (time frame: 1 year). 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 2 May 2025.