Status:
COMPLETED
Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Disorder
Healthy
Eligibility:
All Genders
18-48 years
Phase:
PHASE2
Brief Summary
The overall goal of this project is to determine whether common sleep disturbance patterns, sleep continuity disturbance (SCD) and Sleep Fragmentation (SF), alter cerebral study drug receptor availabi...
Detailed Description
Based on preclinical data and preliminary studies, the investigators hypothesize that sleep continuity disruption (SCD) and/or sleep fragmentation (SF), two sleep patterns commonly observed in both ch...
Eligibility Criteria
Inclusion
- Healthy, 18-48 year olds meeting criteria for Normal Sleep
- Sleep phase within 21:00 and 08:00
- Total sleep time \>6.5 and ≤8.5 hours/night; sleep efficiency ≥85%
- Non-smokers/nicotine users
- Low caffeine users (≤ 2 cups, q.d.).
- Life-time history of exposure to opioids, appropriately prescribed for pain.
Exclusion
- BMI \>35
- Lifetime history of chronic pain
- Acute pain
- Meet clinical criteria for a sleep disorder
- Significant central nervous system disease (e.g., lupus, multiple sclerosis)
- Cognitive impairment, brain injury or history of closed head injury with loss of consciousness over 3 mins
- Other significant medical or psychiatric morbidity within 6 months or lifetime history of bipolar disorder, psychotic disorder, seizure disorder
- Use in the last three months of the following: antidepressants, neuroleptics, sedative hypnotics, isoniazid, glucocorticoids, psychostimulants, opioids
- Any contraindicated medical condition
- Lifetime history of alcohol or substance used disorder
- Clinically significant abnormal complete blood count, hepatic, renal or metabolic panel
- Positive toxicology screen for opioids or recreational drugs
- Pregnant or lactating women
- Significant preadmission psychological distress
- Embedded metal objects or fragments or electronic devices in the head or body that would present a risk during MRI
- Had exposure to ionizing radiation that in combination with the study's estimated radiation exposure would result in a cumulative exposure, exceeding recommended limits
- Unable to tolerate the scanning environment/ claustrophobia
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04299490
Start Date
November 11 2020
End Date
August 31 2025
Last Update
September 24 2025
Active Locations (1)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21224