Mechanisms of Sleep Disruption Hyperalgesia (ESP2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael T. Smith, Ph.D, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01794689
First received: February 15, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

Twenty percent of Americans suffer from chronic pain. Sleep disturbance is similarly prevalent and among the most common and disabling neurobehavioral problems associated with chronic pain. This research is designed to evaluate the effects of disrupted sleep patterns on mood, inflammation, the perception of pain, and pain relief. This study will help researchers understand the relationship between sleep and pain, and how sleep disturbance might influence chronic pain conditions.


Condition Intervention
Sleep Deprivation
Pain
Drug: Morphine
Drug: Saline Placebo (for Morphine)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Mechanisms of Sleep Disruption Hyperalgesia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Effects of experimental sleep disruption on spinal sensitization via laboratory pain responses in a heat-capsaicin pain model. [ Time Frame: Next day after 2 nights of forced awakenings. ] [ Designated as safety issue: No ]
    Spinal sensitization will be assessed during quantitative sensory testing by measuring primary hyperalgesia and secondary hyperalgesia.


Secondary Outcome Measures:
  • Effects of experimental sleep disruption on opioid analgesia. [ Time Frame: Next day after 2 nights of forced awakenings. ] [ Designated as safety issue: No ]
    After 2 nights of forced awakenings, opioid analgesia will be assessed by measuring primary hyperalgesia, secondary hyperalgesia, and cold pressor pain tolerance.

  • Effects of sleep disruption on cellular and genomic markers of inflammation and characterization of inflammatory activity on laboratory pain responses and opioid analgesia. [ Time Frame: Next day after 2 nights of forced awakenings during quantitative sensory testing; 4 hours pre-morphine administration and 2 hours post-morphine administration. ] [ Designated as safety issue: No ]
    After 2 nights of forced awakenings, during quantitative sensory testing, blood will be drawn pre-and post-morphine/placebo administration to examine markers of inflammation.


Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine
Participants randomized to receive Morphine will receive the injection (0.08mg/kg) via IV bolus over 30 seconds during each experimental quantitative sensory testing session.
Drug: Morphine
0.08mg/kg will be administered to participants randomly assigned to receive the drug via IV bolus during each quantitative sensory testing session (after one night of uninterrupted sleep and after 2 nights of forced awakenings).
Placebo Comparator: Saline Placebo
Participants randomized to receive the saline placebo will receive the injection via IV bolus over 30 seconds during each experimental quantitative sensory testing session.
Drug: Saline Placebo (for Morphine)
Saline Placebo will administered to participants randomly assigned to receive the placebo via IV bolus during each quantitative sensory testing session (after one night of uninterrupted sleep and after 2 nights of forced awakenings).

Detailed Description:

This research is being conducted in order to evaluate the effects of disrupted sleep patterns on mood, inflammation, the perception of pain, and pain relief. This study will help researchers understand the relationship between sleep and pain, and how sleep disturbance might influence chronic pain conditions. Healthy participants will undergo baseline sleep and sleep disruption conditions. Following undisturbed sleep and sleep disruption conditions, sensitivity to pain and analgesic response (via morphine or placebo administration) will be assessed using a heat-capsaicin pain model.

This study will be conducted in 2 major parts—3 screening visits (2 outpatient and 1 inpatient) and 2 experimental inpatient visits. Part 1 of the study will involve a 1-week screening period. This will involve two separate screening visits lasting about 2 hours each. At Screening Visit 1, participants will complete questionnaires, an interview, and undergo toxicology screening. At Screening Visit 2, participants will complete questionnaires, undergo a physical exam, and be familiarized with pain testing procedures. At Screening Visit 3, participants will undergo an inpatient sleep study.

Part 2 will involve two different inpatient admissions. The two admissions will be separated by at least two weeks. During each of the admissions, participants' sleep will be studied at night. The first admission will begin immediately following the overnight sleep study in Screening Visit 3. One of the admissions will be for one night and the other admission will be for three nights. For the one night admission, participants will sleep undisturbed for an 8-hour period. For the three night admission, participants will undergo sleep disruption for two nights in a row. On the third night, participants will be allowed to sleep undisturbed for 8 hours for recovery.

During both inpatient admissions, pain testing procedures will be completed that will last approximately 5 hours during the day. During testing, small amounts of blood will be drawn for analysis. Participants will be randomly assigned to two groups. Group A will be given a standard dose of morphine during pain testing. Group B will be given a placebo during pain testing.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Age 18-48
  • Meets Research Diagnostic Criteria for Normal Sleepers
  • Stable sleep phase within 21:00 and 08:00
  • Total sleep time between 6.5 and 8.5 hours per night
  • Sleep efficiency ≥85%
  • Epworth Sleepiness Scale Score <10
  • Non-smoker/non-nicotine users
  • Low Caffeine Users (≤2 cups per day)

Exclusion Criteria:

  • Body Mass Index ≥35
  • Lifetime history of chronic pain (>6 months)
  • Acute pain
  • Significant medical or psychiatric morbidity within 6 months
  • Lifetime history of bipolar disorder, psychotic disorder, serious recurrent major depression, serious post-traumatic stress disorder, or seizure disorder
  • Respiratory, hepatic, renal, or cardiac conditions that would contraindicate opioid use
  • Lifetime history of alcohol or substance abuse or dependence
  • Lifetime history of opioid use >36 doses or >7 days of consecutive use
  • Prior adverse reaction to general anesthetics, opioids, or capsaicin
  • Clinically significant abnormal complete blood count or comprehensive metabolic profile
  • Positive toxicology screen for opioids or recreational drugs
  • Pregnant or lactating women
  • Significant pre-admission psychological distress (T-scores >64 on the Brief Symptom Inventory Global Scales)
  • Significant lifetime history of serious head injury that is determined to influence pain processing or sleep systems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794689

Contacts
Contact: Mercedes Robinson (410) 550-7912 mrobin75@jhmi.edu
Contact: Michelle Polley mpolley1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Mercedes Robinson, B.S.    410-550-7912    mrobin75@jhmi.edu   
Contact: Michelle Polley, BA    4105507000    mpolley1@jhmi.edu   
Principal Investigator: Michael T. Smith, Ph.D         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Michael Smith, Ph.D Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences
  More Information

No publications provided

Responsible Party: Michael T. Smith, Ph.D, Associate Professor of Psychiatry and Behavioral Medicine; Director, Behavioral Sleep Medicine Program, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01794689     History of Changes
Other Study ID Numbers: NA_00071465, 1R01DA032922-01
Study First Received: February 15, 2013
Last Updated: March 10, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Sleep Deprivation
Sleep Disorders
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dyssomnias
Mental Disorders
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 20, 2014