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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 belowSelect...
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:Select...
I have active hepatitis or my liver enzymes are more than three times the normal limit.
Select...
I have had a major head injury affecting my thinking or a history of seizures.
Select...
I am not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 50 years old.I understand and can follow the study's requirements.You regularly consume a lot of caffeine, more than 500 mg per day.I am diagnosed with a mental health condition and am taking medication for it.Your body mass index (BMI) is between 18 and 30.I am on prescription medications, but not using specific anti-fungal agents or some creams for skin conditions.I have active hepatitis or my liver enzymes are more than three times the normal limit.You smoke more than 5 cigarettes per day.I have had a major head injury affecting my thinking or a history of seizures.I am in good health with no diabetes and normal test results.I am not pregnant.You currently have problems with alcohol or drugs. If you had problems in the past but it was more than 3 years ago, that's okay.You drink a lot of alcohol, more than 15 drinks per week.
Research Study Groups:
This trial has the following groups:- Group 1: Exhaled Breath Samples
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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