NCT00097474

Effects of Hydrocortisone, Melatonin, and Placebo on Jet Lag

Completed Phase 2 Last updated 14 April 2026

What this trial tests

Phase 2 trial testing Hydrocortisone in Jet Lag in 57 participants. Completed in 14 November 2007.

Timeline

21 December 2004

Primary endpoint
6 January 2006

14 November 2007

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	57
Start date	21 December 2004
Primary completion	6 January 2006
Estimated completion	14 November 2007
Sites	1 location across United States

Drugs / interventions tested

• Hydrocortisone (hydrocortisone) — full drug profile →
• Melatonin (MELATONIN) — full drug profile →
• Placebo

Conditions studied

• Jet Lag — all drugs for Jet Lag →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

Adults 18 to 65, any sex, with Jet Lag. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine the effects of cortisol (hydrocortisone), melatonin, a combination of cortisol and melatonin, and placebo (an inactive substance) on jet lag symptoms. Jet lag is a term used to describe symptoms people commonly experience after rapid travel across several time zones. The cause of jet lag is not known, but various hormones, including cortisol and melatonin, have a day-to-night pattern of secretion and play a role in maintaining the body's internal rhythms. This study will test whether taking cortisol, melatonin, or both can help re-establish the body's day-night cycle and result in less jet lag.

People between 18 and 65 years of age who are planning a non-stop eastward flight with the following characteristics may be eligible for this study:

* Crossing six to eight time zones (6 to 8 hours difference between Eastern Standard Time and the destination)
* Destination between 30 and 50 latitudes (approximately Cairo to London)
* Evening flight (5 PM to midnight) with morning arrival
* Remaining abroad at least 4-10 days

Candidates must have a body mass index (BMI) between 20 and 30 kg/M (not too thin and not overweight) and must not be taking medicines that affect sleep or cortisol or melatonin levels. Prospective participants are screened with a medical history, blood tests, and check of blood pressure, height, and weight.

Pre-flight Procedures

Participants keep a sleep journal 3 days before the flight. For 1 day within 3 days of the flight they fill out jet lag and sleepiness questionnaires and collect morning and bedtime saliva samples for measurement of cortisol and melatonin. The saliva is collected by chewing on two small cotton pads and spitting them into a tube. Premenopausal women provide a urine sample the week before the flight to test for pregnancy. On the day of the flight, the participants do not collect saliva or fill out sleep logs or questionnaires. They are given two bottles with study medication. One bottle, labeled "AM," contains either hydrocortisone or placebo; the other, labeled "PM," contains either melatonin or placebo.

Post-flight Procedures

Upon arriving at their destination in the morning, participants obtain a saliva sample and take one of the capsules in the "AM" bottle. At bedtime, they collect saliva and then take one of the "PM" capsules. They repeat the medication doses for a total of 4 days and repeat the saliva collections on days 2 through 4, 7 and 10 after arrival. In addition, participants complete jet lag and sleep questionnaires in the morning, afternoon, and just before bedtime on the day of arrival and on days 2 through 4, 7 and 10.

After they return from their trip, participants are seen at the NIH Clinic to bring in their saliva specimens and review their questionnaires with study investigators.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Approaches to the Pharmacological Management of Jet Lag.
   Arendt J. · · 2018 · cited 30× · PMID 30167980 · DOI 10.1007/s40265-018-0973-8
2. Personalized medicine for pathological circadian dysfunctions.
   Skelton RL, Kornhauser JM, Tate BA. · · 2015 · cited 5× · PMID 26150790 · DOI 10.3389/fphar.2015.00125