Detecting Drugs of Abuse Via Exhaled Breath Samples Using Differential Mobility Spectrometry

April 29, 2025 updated by: Scott Lukas, Mclean Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy adult male and female volunteers

Description

Inclusion Criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exhaled Breath Samples
Quantitative detection of marijuana, morphine or fentanyl through exhaled breath
Drug: Marihuana
Two doses of marijuana given.
Device: BID2 Instrument - breathalyzer
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath/cannabinoids concentrations
Time Frame: 1 year
Quantitatively measuring cannabinoids in exhaled breath
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Collaborators

VOX BIOMEDICAL LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

March 19, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P001633
  • 5R42DA049655-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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