Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia

Official Title: “Melatonin Replacement for Treatment of Sleep Disruption”

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.

Intervention(s) in this Clinical Trial

• Drug: Ramelteon
  • 8 mg nightly
• Drug: Placebo
  • Nightly 8mg of placebo (same appearance as ramelteon)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Ramelteon
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Improvement in subjective and objective sleep parameters
  • Time Frame: 10 weeks
    Safety Issue?: No

Secondary Measures

• Improvement in daytime alertness and overall quality of life.
  • Time Frame: 10 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Age 18 years or older, male or female veterans of any racial or ethnic group
• 2. Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal cord
• 3. Absence of melatonin production
• 4. Time since SCI is greater than 6 months [no cases of acute SCI]
• 5. Subjective complaint of sleep disruption

Exclusion Criteria:

• 1. 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
• 2. Hepatic dysfunction
• 3. Concomitant use of over-the-counter melatonin
• 4. Pregnancy or breast feeding
• 5. Currently or have within the past six months met DSM-IV criteria for drug or alcohol abuse or dependence or AUDIT score >19
• 6. Acute illness or unstable chronic illness. Use of continuous positive airway pressure (CPAP) for treatment of sleep apnea is acceptable.
• 7. No travel across three or more time zones within three weeks or during the protocol
• 8. Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Department of Veterans Affairs U.S. Fed

Overall Clinical Trial Officials and Contacts

Jamie Zeitzer, PhD Principal Investigator VA Palo Alto Health Care System  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00507546

Study ID Number: B6010R

ClinicalTrials.gov Identifier: NCT00507546

Health Authority: United States: Federal Government