Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 4

Conditions: Sleep Disorders; Tetraplegia; Insomnia; Spinal Cord Injury

Treatments: Drug: Ramelteon; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00507546

B6010-R

06-038R (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 2 patient groups

Ramelteon then placebo

Experimental group

Description:

8 mg nightly ramelteon for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of nightly placebo (cross-over)

Treatment:

Drug: Ramelteon

Placebo then ramelteon

Experimental group

Description:

placebo nightly for three weeks, followed by two weeks of nightly placebo (washout), then three weeks of 8 mg nightly ramelteon (cross-over)

Treatment:

Drug: Placebo