Comparison of drug screening methods using fingerprint sweat
User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison and Usability
This study is testing a new way to screen for drugs using fingerprint sweat to see if it works as well as traditional lab tests in healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Intelligent Bio Solutions Inc. Industry-sponsored |
| Locations | 3 sites (Decatur, Georgia and 2 other locations) |
| Trial ID | NCT06618183 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the accuracy and usability of the Intelligent Fingerprinting Drug Screening System by comparing its test results with those obtained from a validated laboratory technique. The study involves healthy male and non-pregnant female participants who provide fingerprint sweat specimens after being administered varying doses of codeine sulfate. Operators, who are trained users of the screening system, will conduct the tests and assess the system's performance in a controlled environment. The primary focus is on measuring the sensitivity, specificity, and accuracy of the drug screening system.
Who should consider this trial
Good fit: Ideal candidates are healthy males and non-pregnant females aged 18 to 65 with a BMI between 18 and 30.
Not a fit: Patients who are pregnant, have significant health issues, or are outside the specified age and BMI range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the reliability and efficiency of drug screening processes in various settings, including employment.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in drug screening methodologies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English.
2. \*Completed the screening process within 30 days prior to dosing. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures, provided all the required screening procedures have been performed within 30 days prior to dosing.
3. Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at the time of dosing.
4. \*Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60 kg.
5. \*Females of childbearing potential must be willing to practice an acceptable form of contraception (see Section 9.3.3), and have a negative urine pregnancy test on admission to the treatment phase of the study.
6. \*Males must agree to practice an acceptable form of contraception.
7. \*Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation.
Exclusion Criteria:
1. Unwilling or unable to provide informed consent.
2. \*More than three digits absent from the hands due to congenital or accidental cause(s).
3. \*Reports receiving any investigational drug within 30 days prior to dosing.
4. \*Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
5. \*Reports any personal history of substance abuse (including drug/alcohol abuse or addiction) or mental illness (e.g. major depression) within one year prior to screening visit.
6. \*Is pregnant (females only).
7. \*Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
8. \*Reports history of respiratory depression (e.g., sleep apnea).
9. \*Current severe hypotension (i.e., systolic blood pressure \<90 mmHg).
10. \*Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
11. \*Reports current presence of acute bronchial asthma/ upper airway obstruction.
12. \*Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
13. \*Reports history or current condition of adrenal insufficiency.
14. \*Reports history or current condition of renal disease.
15. If, in the opinion of the Investigator, the subject is not suitable for the study.
* Required only for \"donors.\" Not required for \"operators.\"
Where this trial is running
Decatur, Georgia and 2 other locations
- CenExel iResearch — Decatur, Georgia, United States (Recruiting)
- CenExel HRI — Berlin, New Jersey, United States (Recruiting)
- CenExel HRI — Marlton, New Jersey, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.