Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug

Description

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.

Conditions

Sleep Disorder, Healthy

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Study Overview

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Study Details

Study overview

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.

Effects of Experimental Sleep Disruption and Fragmentation on Study Drug Receptor Function, Receptor Agonist Analgesia, and Abuse Liability

Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug

Condition
Sleep Disorder
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins School of Medicine, Baltimore, Maryland, United States, 21224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 48 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Johns Hopkins University,

Eric C Strain, MD, STUDY_CHAIR, Johns Hopkins University

Naresh Punjabi, MD, STUDY_CHAIR, Johns Hopkins University

Claudia Campbell, PhD, STUDY_CHAIR, Johns Hopkins University

Patrick H Finan, PhD, STUDY_CHAIR, Johns Hopkins University

Jeannie Leoutsakos, PhD, STUDY_CHAIR, Johns Hopkins University

Hiroto Kuwabara, MD, STUDY_CHAIR, Johns Hopkins University

Alexandra Kearson, BA, STUDY_CHAIR, Johns Hopkins University

Michael T Smith, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2025-03-31