Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

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 availability, drug-based analgesia, and drug abuse liability. The investigators specifically aim to: 1) evaluate whether experimental SCD and/or SF alter resting or pain-evoked receptor binding potential in brain regions associated with pain inhibition; 2) examine whether SCD and/or SF alters the analgesic response and abuse liability profile of a study medication; and 3) determine whether receptor binding potentials in brain regions of interest are associated with study medication analgesia and abuse liability. The investigators will also evaluate the extent to which associations differ by sleep condition or sex.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Analgesics; Analgesics, Opioid; Central Nervous System Stimulants

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