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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)
Capable of understanding and complying with the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 understand and can follow the study's requirements.
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I am in good health with no diabetes and normal test results.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Breath/cannabinoids concentrations

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
212 Previous Clinical Trials
21,544 Total Patients Enrolled
2 Trials studying Opioid Abuse
169 Patients Enrolled for Opioid Abuse

Media Library

Exhaled Breath Samples Clinical Trial Eligibility Overview. Trial Name: NCT05384470 — Phase 2
Opioid Abuse Research Study Groups: Exhaled Breath Samples
Opioid 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for new participants to join this clinical research?

"Correct. The data available on clinicaltrials.gov elucidates that this research endeavor, which was initially posted on July 1st 2021, is actively looking for participants. Approximately 50 patients need to be selected from just one medical center."

Answered by AI

Are participants over 25 years of age qualified for enrollment in this trial?

"Complying with the trial's requirements, individuals who are 21 years old or older and younger than 50 can join."

Answered by AI

Is it feasible for me to partake in this experiment?

"To be selected in this clinical trial, prospective participants should present evidence of hashish abuse and fall between 21 to 50 years old. Approximately fifty individuals are going to be admitted into the experiment."

Answered by AI

Has this therapeutic intervention been officially sanctioned by the FDA?

"As this is a Phase 2 trial, the perceived safety of this intervention has been evaluated as a '2' given that while there are some data points supporting its safety, no reports on efficacy have yet been observed."

Answered by AI

What is the cap on participants for this trial?

"Affirmative. Clinicaltrials.gov states that the trial, which was originally advertised on 7/1/2021, is currently searching for participants. Specifically, 50 individuals are required to be enrolled from one site."

Answered by AI
~8 spots leftby Oct 2024