Overview

Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
US Department of Veterans Affairs
VA Office of Research and Development
Collaborators:
Stanford University
Takeda
Treatments:
Melatonin
Criteria
Inclusion Criteria:

- Age 18 years or older, male or female veterans of any racial or ethnic group

- Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal
cord

- Absence of melatonin production

- Time since SCI is greater than 6 months [no cases of acute spinal cord injury]

- Subjective complaint of sleep disruption

Exclusion Criteria:

- Current use of fluvoxamine (Luvox , antidepressant), rifampin (antimycobacterial),
ketoconazole (Nizoral , antifungal), or fluconazole (Diflucan , antifungal) [these
interact with the same liver enzyme that is the primary metabolizer of ramelteon]; use
of sleep medications is okay

- Hepatic dysfunction

- Concomitant use of over-the-counter melatonin

- Pregnancy or breast feeding

- Currently or have within the past six months met DSM-IV (Diagnosis and Statistical
Manual IV) criteria for drug or alcohol abuse or dependence or AUDIT score >19

- Acute illness or unstable chronic illness. Use of continuous positive airway pressure
(CPAP) for treatment of sleep apnea is acceptable.

- No travel across three or more time zones within three weeks or during the protocol

- Illiterate or unable to read or write English or are judged by the investigator to be
unable or unlikely to follow the study protocol