Clinical trial NCT06382610: Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations
Official title: Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: melatonin
transdermal
oral
pharmacokinetics
Lead sponsor: University of Redlands
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated measures crossover trial
Primary purpose: BASIC_SCIENCE

Brief summary: Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body.

Detailed description: Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. A previous study (unpublished) has shown that a small amount of an over-the-counter lotion increases salivary melatonin levels by up to 1000 fold, a startling amount. Researchers will characterize the time course of the absorption and metabolism of lotion- and bubble bath-based melatonin compared to oral tablets in healthy 18-22 year olds.

The peak level, time to peak level and half-life of melatonin will be compared between the administration routes using a within-person (repeated measures) design and saliva sampling over 48 hours. Participants can choose specific days to participate within a one-month window, with a maximum of four sampling periods. All participants will collect control saliva samples (no melatonin treatment) one night at 10 PM and 4 AM. Participants will be asked to have two treatments 1) oral melatonin and 2) either lotion melatonin or bubble-bath melatonin. Participants can indicate if they have a preference for lotion vs. bubble bath or if they are willing to undergo both lotion and bubble bath treatments (adding a fourth sampling period). Order will be randomized.

For the treatments, saliva sampling times are as follows: Prior to melatonin administration (10 AM), then 15 min, 30 min, 45 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours (10 PM), 18 hours (4 AM), 24 hours, 36 hours, and 48 hours after administration. Samples will be frozen at the participant's home until returned to the researchers at a later date. Melatonin in saliva samples will be quantitated via Enzyme Linked Immunosorbent Assay.

Eligibility criteria: Inclusion Criteria:

* University of Redlands student

Exclusion Criteria:

* Allergies or sensitivities to scented lotions or bath products
* Pregnancy

Primary outcomes:
measure: Salivary melatonin level
timeFrame: from immediately prior to administration to 48 hours post administration
Secondary outcomes:
measure: Side effects
timeFrame: from immediately prior to administration to 48 hours post administration
Other outcomes:
Locations:
city: Redlands
country: United States
facility: University of Redlands
state: California
Study officials:
affiliation: University of Redlands
name: Lisa E Olson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: