Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Insomnia Spinal Cord Injury Tetraplegia Sleep Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ramelteon then placebo

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

Group Type EXPERIMENTAL

Ramelteon

Intervention Type DRUG

8 mg nightly

Placebo then ramelteon

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Nightly 8mg of placebo (same appearance as ramelteon)

Interventions

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Ramelteon

8 mg nightly

Intervention Type DRUG

Placebo

Nightly 8mg of placebo (same appearance as ramelteon)

Intervention Type DRUG

Other Intervention Names

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Rozerem

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes