Status:
COMPLETED
Detecting Drugs of Abuse Via Exhaled Breath Samples Using Differential Mobility Spectrometry
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
VOX BIOMEDICAL LLC
Conditions:
Opiate Abuse
Marijuana Abuse
Eligibility:
All Genders
21-50 years
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.
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 brea...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05384470
Start Date
August 1 2021
End Date
August 15 2024
Last Update
May 2 2025
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478