Efficacy and Safety Study of Propofol Infusion for Refractory Chronic Primary Insomnia

Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Age Range:18 - 65
Start Date:June 2013
Contact:Dr. Steven Hirsh

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An Open Label, Pilot Study Utilizing an IV Infusion of Propofol in Male and Female Volunteers With Refractory Chronic Primary Insomnia

Insomnia is a widespread condition in which approximately one-third of adults in the United
States are symptomatic with 6% of the population meeting the diagnostic criteria for
insomnia. There is an increased risk of insomnia in certain segments of the population
including women, middle-aged and older adults, shift workers and individuals with medical or
psychiatric disorders. Individuals with insomnia have a decreased quality of life compared
to those who report other serious illnesses such as major depression and congestive heart
failure. Chronic insomnia can be caused by medications, drug or alcohol abuse, psychiatric
disorders, medical and neurologic disorders. It can impair cognitive and physical

Propofol is an approved drug administered intravenously for use in the induction and
maintenance of anesthesia or sedation. Some research suggests that propofol when
administered as a two hour infusion may improve the ease of sleep onset, sleep quality, ease
of awakening and the integrity of behavior following waking.

This study will be conducted in the Broward Health Medical Center Sleep Lab, under the
direct care of a Board Certified Anesthesiologist, dedicated to the study involving
participants who have refractory chronic primary insomnia and have not responded to
conventional pharmacologic therapies within the past 90 days. Each qualifying participant
will receive an IV infusion of the study medication for 5 consecutive nights. Assessments
including polysomnography with completion of questionnaires will occur at screening, Days 1
through 5 of study product administration, Day 6 and Day 90. Follow-up questionnaires will
also be distributed on Day 180.

Inclusion Criteria:

- Ambulatory, male or non-pregnant, non-lactating female, 18-65 years of age.

- Overall healthy with no other sleep disorder such as sleep apnea or periodic limb
movement disorder

- Has not responded to conventional pharmacologic therapies (benzodiazepines and
non-benzodiazepines) within the past 90 days. The non-benzodiazepine therapies can
include melatonin and melatonin receptor agonists, antihistamines, antidepressants,
over-the-counter medications, supplements or herbs for sleep

- Have refractory chronic primary insomnia (chronic-inadequate quantity or quality of
sleep characterized by a subjective report of difficulty with sleep initiation,
duration, consolidation, or quality that occurs despite adequate opportunity for
sleep, and results in some form of daytime impairment and has persisted for at least
one month., primary-insomnia independent of any known physical or mental condition,
refractory-not yielding, at least not yielding readily to treatment based upon
polysomnography at baseline, total sleep time (sTST) of < 6 hr, a subjective wake
time after sleep onset (WASO) of >1 hr, a subjective latency to sleep onset (SOL) of
> 20 min

- Willing and able to give written informed consent

- Clearly understands the procedures and requirements for the study

- Willing and able to comply with all study procedures and data recording obligations
for the entire length of the study

- Have no clinically significant abnormalities on the basis of medical history,
physical examination and vital signs in the judgment of the investigator and/or

- Ability and willingness to abstain from any pharmaceutical or over-the-counter
medication for sleep as well as alcohol from 72 hours prior to baseline and the first
dose until after completion of the Study Product Administration Follow-Up Visit (Day
6) as well as 72 hours prior to the Day 90 visit.

- All values for hematology and for clinical chemistry tests of blood within the normal
range for age and gender or showing no clinically relevant deviations as judged by
the investigator

- Nonsmoking or have quit smoking at least 6 months prior to dosing

Exclusion Criteria:

- Having any medical conditions including diabetes, cardiovascular disease, pulmonary,
renal, endocrine, hepatic, neurologic, psychiatric (including depression),
immunologic, hematologic, gastrointestinal or metabolic disease requiring medical
treatment that would preclude participation into the study in the judgment of the

- Having ingested any pharmaceutical or over-the-counter sleep product within 72 hours
of dosing as well as 72 hours prior to the Day 90 visit.

- Taking any medication that can yield a moderate to major drug interaction with
propofol including those with CNS (central nervous system)-depressant effects

- Having had a history of any medical or surgical procedure that would preclude
participation into the study in the judgment of the investigator/sub-investigator

- Being pregnant, planning on becoming pregnant, breast feeding or unwilling to use a
medically acceptable form of birth control during the study (with at least one
acceptable barrier for a period of one month prior to the beginning of the study
until at least three months after study completion) or are surgically sterile or
postmenopausal (at least 12 months without a period).

- Having a systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg, or
blood pressure that would preclude participation in the judgment of the

- Having a previous history of abnormal screening laboratory test values: bilirubin > 2
x ULN (upper limit of normal), AST(aspartate aminotransferase) and ALT (alanine
aminotransferase) > 2 x ULN (upper limit of normal), serum creatinine > 1.5 mg/dl,
fasting blood glucose below 85mg/dl or above 110 mg/dl, calcium level < 8.6 mg/dl and
triglycerides >200.0mg/dl.

- Any type of active malignancy (except non-melanomatous skin malignancies) within the
past 5 years

- History of known or suspected substance abuse

- Currently consume more than 7 standard alcoholic drinks per week and unable to
refrain from consuming an alcoholic beverage during the course of the study dosing

- Currently consume more than 14 caffeinated beverages per week and unable to refrain
from consuming a caffeinated beverage within 8 hours prior to dosing.

- History of allergy to any anesthetic, eggs, egg products, soybeans or soy products as
well as hypersensitivity to Propofol or any of its components

- Unable to avoid engaging in a hazardous occupation requiring complete mental
alertness and/or motor coordination after receiving the study product.

- Participation in another study within 30 days prior to dosing.

- Donated blood within 30 days prior to dosing.

- Illness within five days prior to dosing

- Having a pacemaker or any internal medical device

- In the opinion of the investigator, not suitable for entry into the study.
We found this trial at
1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
Fort Lauderdale, FL
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