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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mclean Hospital
• Collaborator: Jacob Golde, VOX BIOMEDICAL LLC 42 Wiggins Ave Bedford, MA 017302348

Criteria

The subject must be capable of understanding and complying with the protocol. Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, including absences 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). Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT)> 3x the upper limit of normal. For female volunteers, a positive pregnancy test.