Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug

Launched by JOHNS HOPKINS UNIVERSITY · Mar 5, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of sleep disturbances might affect how a study medication works in the brain, especially in relation to pain relief and the potential for misuse. Researchers want to understand if specific sleep problems, such as having trouble staying asleep or experiencing interrupted sleep, change the way the medication binds to brain receptors that help manage pain. They will also explore whether these sleep issues affect how well the medication relieves pain and if it could lead to any misuse. The study aims to see if these effects vary based on the type of sleep disturbance or whether the participant is male or female.

To participate in this trial, you need to be a healthy adult between 18 and 48 years old with normal sleep patterns, meaning you sleep between 6.5 and 8.5 hours each night and don't have any sleep disorders. You also need to be a non-smoker and limit your caffeine intake. If you join, you can expect to undergo some tests, possibly including brain scans, to help researchers gather information about how your brain responds to the study medication. It's important to note that certain medical and psychological conditions may prevent you from participating, so the study team will carefully review your health history before enrolling you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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