Detecting Drugs of Abuse Via Exhaled Breath Samples Using Differential Mobility Spectrometry (NCT05384470) | Clinical Trial Compass
CompletedNot Applicable
Detecting Drugs of Abuse Via Exhaled Breath Samples Using Differential Mobility Spectrometry
United States32 participantsStarted 2021-08-01
Plain-language 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.
Who can participate
Age range
21 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.