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

NCT05384470 | Completed FDA Device

• 2 other identifiers: 2019P0016335R42DA049655-04
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opiate Abuse; Marijuana Abuse; Diagnostic

Keywords

THC; marihuana; pharmacokinetics; breathalyzer

Outcome Measures

Primary Outcomes (1)

• Breath/cannabinoids concentrations

  Quantitatively measuring cannabinoids in exhaled breath

  1 year

Study Arms (1)

Exhaled Breath Samples

Quantitative detection of marijuana, morphine or fentanyl through exhaled breath

Drug: Marihuana; Device: BID2 Instrument - breathalyzer

Interventions

Marihuana DRUG

Two doses of marijuana given.

Exhaled Breath Samples

BID2 Instrument - breathalyzer DEVICE

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.

Exhaled Breath Samples

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult male and female volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mclean Hospital: lead
• VOX BIOMEDICAL LLC: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Marijuana Abuse; Disease

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, McLean Imaging Center and BPRL

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 20, 2022
• Study Start: August 1, 2021
• Primary Completion: March 19, 2024
• Study Completion: August 15, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

US (1)