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Breathalyzer for Drug Abuse

Phase 2
Recruiting
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusive Age 21-50 years (age will be verified by driver's license or other valid form of identification)
In good physical and mental health (normal physical exam, ECG, blood and urine chemistries, absence of history or laboratory evidence of diabetes)
Must not have
Has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT)> 3x the upper limit of normal
History of major head trauma resulting in cognitive impairment or history of seizure disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a device that can detect marijuana and opioids in breath samples, to see if it is accurate and works well.

Who is the study for?
This trial is for healthy adults aged 21-50 with a BMI of 18-30, who understand the study and have stable housing. Participants must not use tobacco heavily, take certain medications, or have a history of major head trauma, liver issues, pregnancy, heavy alcohol or caffeine use. Past substance abuse is okay if it was over three years ago.
What is being tested?
The trial is testing a new device called BID2 that detects marijuana and opioids in breath samples. It aims to validate this breathalyzer's effectiveness in identifying drug use as part of a Phase II STTR program.
What are the potential side effects?
Since the intervention involves using a breathalyzer device (BID2) and providing breath samples without direct administration of drugs or invasive procedures, no significant side effects are expected from participating in this clinical trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 50 years old.
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I am in good health with no diabetes and normal test results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active hepatitis or my liver enzymes are more than three times the normal limit.
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I have had a major head injury affecting my thinking or a history of seizures.
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I am not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Breath/cannabinoids concentrations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Exhaled Breath SamplesExperimental Treatment2 Interventions
Quantitative detection of marijuana, morphine or fentanyl through exhaled breath

Find a Location

Who is running the clinical trial?

VOX BIOMEDICAL LLCUNKNOWN
Mclean HospitalLead Sponsor
216 Previous Clinical Trials
21,823 Total Patients Enrolled

Media Library

Exhaled Breath Samples Clinical Trial Eligibility Overview. Trial Name: NCT05384470 — Phase 2
Cannabis Abuse Research Study Groups: Exhaled Breath Samples
Cannabis Abuse Clinical Trial 2023: Exhaled Breath Samples Highlights & Side Effects. Trial Name: NCT05384470 — Phase 2
Exhaled Breath Samples 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384470 — Phase 2
~12 spots leftby Oct 2025