Could a few drops under the tongue replace a needle? atropine study explores

NCT ID NCT06366087

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether atropine eye drops placed under the tongue enter the bloodstream as effectively as a standard injection. Forty-six healthy adults each received both forms in random order. Researchers measured drug levels in blood samples over eight hours to see if the two methods are bioequivalent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atropine sulfate
What this could lead to
If successful, this could show that giving atropine under the tongue is a safe and effective alternative to injections, which could be useful in emergencies.
What could go wrong
This is a small, early-phase study in healthy volunteers, not patients. It only measures drug levels in the blood, not actual treatment effects, so real-world benefits are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

46 people

The number who actually took part.

Started

Apr 2024

Finished

May 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male and non-pregnant female volunteers between the ages of 18 and 65 years, inclusive, at time of consent. 2. Willing and able to provide written informed consent. 3. Females who are of childbearing potential and are sexually active with a male partner must have used an adequate method of birth control for at least 2 months prior to Screening and must agree to continue using an adequate method of birth control from Screening through Follow-up (Day 15). 1. A female of childbearing potential is defined as a post onset of menarche and premenopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal \>2 years, tubal ligation \>1 year, bilateral salpingo-oophorectomy, or hysterectomy. 2. Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label. Examples include oral contraceptives, injectable progestogen, implants of etonogestrel or levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device or intrauterine system, or male partner sterilization at least 6 months prior to the participant's Screening Visit. 4. In the judgment of the investigator, the participant is in good health, based on review of medical history and the results of Screening evaluation (including vital signs, physical examination, 12-lead electrocardiogram \[ECG\], and Screening laboratory assessments, performed no more than 14 days prior to randomization into the study). 5. Able to comply with the dosing instructions and available to complete the study Schedule of Assessments. Exclusion Criteria: 1. Females who have a positive pregnancy test or who are breastfeeding. 2. Participants with thyroid disease as evidenced by a thyroid-stimulating hormone (TSH) \<0.9 × lower limit of normal (LLN) or \> 1.2 × upper limit of normal (ULN) at Screening (This Screening test will not be repeated prior to subsequent dosing). 3. Participants with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine \>1.5 × ULN at Screening. (These Screening tests will not be repeated prior to subsequent dosing.) 4. Have known human immunodeficiency virus (HIV), or acute or chronic hepatitis B or hepatitis C infection based on medical history; or test positive for any of these at Screening. Participants who have been effectively treated for hepatitis C, as evidenced by a negative hepatitis C RNA confirmation test and who no longer require antiviral therapy, are eligible for participation. (These Screening tests will not be repeated prior to subsequent dosing.) 5. Participants who took any prescription medications (with the exception of oral contraceptives or hormone replacement therapy) within 30 days of Screening. Prior to each dose, the investigator will review prohibited medication use and determine whether the participant should be terminated from further dosing. 6. Participants who took any over-the-counter medication/vitamins/herbal supplements in the last 72 hours prior to Screening. Prior to each dose, the investigator will review prohibited medication use and determine whether the participant should be terminated from further dosing. 7. Participants who are current smokers or are currently using any oral nicotine/oral tobacco product (e.g. snuff, chew, lozenges, nicotine gum, pouches) or electronic cigarette or vaping device (e.g., e-cigarette, mod, vape pen, JUUL, e-cigar, e-hookah, e-pipe, vape pods) or have used any of these products within 6 months prior to Screening. 8. Participants with glaucoma and/or history of ocular surgery (including LasikTM), ocular trauma, or congenital ocular disorder. 9. Participants with any history of heart disease, including but not limited to hypertension, coronary artery disease, arrhythmia (treated or untreated), congestive heart failure, pacemaker, history of vasovagal syncope, any supraventricular tachycardia, peripheral vascular disease, or claudication. 10. Participants with clinically significant arrhythmias or abnormal conduction; abnormal conduction is defined as a prolonged PR or QRS, or a QTc ≥450 msec for males or ≥470 msec for females. 11. Participants with a history of partial organic pyloric stenosis, chronic constipation, gastroparesis, or other gastrointestinal motility issues. 12. Participants with a history of xerostomia due to an underlying disease or previous radiation therapy to the head and neck. 13. Males with history of symptomatic prostatic hypertrophy; males or females with a history of urinary hesitancy or retention. 14. Participants with a blood pressure \>140/90 mm Hg taken after the participant has been seated and resting for at least five minutes. 15. Participants with a history or current diagnosis of myasthenia gravis. 16. Participants who have donated blood within 8 weeks of Screening or intend to donate blood during the study period. 17. Participants with a history of drug or alcohol abuse in the last two years or evidence of a positive urine drug test at Screening. (This Screening test will not be repeated prior to subsequent dosing.) 18. Participants with a known sensitivity or prior adverse reaction to atropine. 19. Participants who have consumed alcohol within 24 hours prior to each Pre-dose Visit. (This will be assessed only at Visit 1 \[Pre-dose\] and Visit 2 \[Pre-dose\].) 20. Participants with any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled, would interfere with SL or IM administration of study drug, or would otherwise interfere with interpretation of study results.

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Contacts and locations

Locations

  • Johnson County Clin-Trials (JCCT)

    Lenexa, Kansas, 66219, United States