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