Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-06-30

Brief Summary

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The broad objective of this investigation is to assess the safety and efficacy of oral therapy with dexmedetomidine for the induction and maintenance of restful sleep.

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Detailed Description

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Sleep is a basic human function that occupies approximately one-third of our lives. Much of what is known about the benefits of sleep in humans has been obtained from studies of patients with insomnia, the most common sleep disorder with a reported prevalence of 10 to 15%. Unfortunately, insomnia is an independent risk factor for acute myocardial infarction, coronary heart disease, heart failure, hypertension, diabetes, and death. More so, sleep disturbances lead to neurocognitive deficits such as delirium and psychosis. However, the principal medications (i.e. benzodiazepines, zolpidem) currently used to treat insomnia are associated with side effects such as daytime sedation, delirium, anterograde memory disturbance, and complex sleep-related behaviors. We recently found that a nighttime intravenous bolus administration of dexmedetomidine was associated with normal sleep architecture comprising of rapid eye movement (REM) and non-REM (N1, N2, N3) sleep, with improved next-day psychomotor vigilance performance compared to zolpidem. Presently, dexmedetomidine is only available in an intravenous formulation. The goal of this project is to develop dexmedetomidine, an alpha-2 receptor agonist, into an oral sleep therapeutic with a neurocognitive sparing profile.

Conditions

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Sleep Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will receive both the oral dexmedetomidine intervention and placebo comparator in a randomized order.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oral Dexmedetomidine, Then Placebo

This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Oral form

Saline Placebo

Intervention Type OTHER

Saline Placebo

Placebo, Then Oral Dexmedetomidine

This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine .

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Oral form

Saline Placebo

Intervention Type OTHER

Saline Placebo

Interventions

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Dexmedetomidine

Oral form

Intervention Type DRUG

Saline Placebo

Intervention Type OTHER

Other Intervention Names

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Precedex Saline

Eligibility Criteria

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Inclusion Criteria

* Age between 18-50
* Native English speaking
* ASA physical status classification P1 and P2 (stable chronic condition)
* Normal body habitus.

Exclusion Criteria

* Abnormal sleep habits
* Sleeping less than 5 hours each night
* Going to sleep before 9:00 PM or after 2:00 AM on a regular basis
* Waking up before 5:00 AM or after 10:00 AM on a regular basis.
* Takes medication that alters sleep, cognitive function, or both. -Has a history of a known neurological or psychiatric problem.
* Younger than 18 or older than 50 years of age.
* Known or suspected sleep disorder(s).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes