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Sleep Disturbance + Study Drug for Sleep Disorders (Sleep-MOR Trial)
Phase 2
Recruiting
Led By Michael T Smith, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 minutes on day 3 of inpatient visit
Awards & highlights
Sleep-MOR Trial Summary
This trial is looking at whether sleep disturbance alters the way people respond to pain medication and whether it makes the medication more likely to be abused.
Who is the study for?
This trial is for healthy adults aged 18-48 who sleep well (6.5 to 8.5 hours a night with good quality), don't smoke or use nicotine, and consume little caffeine. They must have had some exposure to opioids in the past but can't be overweight, have sleep disorders, metal implants unsafe for MRI, significant neurological diseases, recent serious medical issues or substance abuse history.Check my eligibility
What is being tested?
The study tests how different types of sleep disturbances affect the brain's response to various drugs including stimulants, benzodiazepines, opioids, cannabinoids and pain relievers compared to placebo. It looks at drug effects on pain relief and potential for misuse under normal sleep conditions versus disrupted sleep.See study design
What are the potential side effects?
Potential side effects depend on the specific medication given but may include drowsiness or alertness (for sedatives and stimulants respectively), addiction risk (opioids), changes in mood or appetite (cannabinoids) and typical over-the-counter medication risks like stomach upset.
Sleep-MOR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 minutes on day 3 of inpatient visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 minutes on day 3 of inpatient visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Drug Effects as assessed by the Visual Analog Scale
Percent change in receptor binding potential from PET scan
The monetary valuation in dollars of the study medication as assessed by the Drug or Money Multiple Choice Questionnaire
+1 moreSleep-MOR Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Sleep FragmentationExperimental Treatment2 Interventions
The Sleep fragmentation condition will be conducted on two consecutive nights. Subjects are provided an 8-hour sleep opportunity during which their sleep will be disturbed by microarousals that simulate sleep apnea.
Group II: Sleep Continuity DisruptionExperimental Treatment2 Interventions
The Sleep Continuity Disruption condition will be conducted on two consecutive nights. An 8-hour sleep opportunity period will be disturbed by several forced awakenings at random intervals during which no sleep is permitted.
Group III: Undisturbed SleepActive Control2 Interventions
An 8-hour period of undisturbed sleep is permitted on each night.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,317 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,036 Total Patients Enrolled
Claudia Campbell, PhDStudy ChairJohns Hopkins University
3 Previous Clinical Trials
117 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is over 35.I am currently experiencing severe pain.You feel uncomfortable in small, enclosed spaces.You have a history of alcohol or drug addiction.You have metal objects or electronic devices in your body that could be unsafe during an MRI.You have tested positive for opioids or recreational drugs in a drug test.I have not had significant health or mental health issues in the past 6 months, nor do I have a history of bipolar, psychotic disorders, or seizures.I have had a head injury that made me unconscious for more than 3 minutes.You drink two cups of coffee or less per day.I have experienced chronic pain for a long time.I have not used antidepressants, sedatives, or similar drugs in the last 3 months.I do not have major brain or nerve diseases like lupus or MS.I have been experiencing significant emotional or mental distress before being admitted.You sleep between 6.5 and 8.5 hours per night and have a sleep efficiency of at least 85%.You have taken opioids for pain in the past.You drink two or fewer cups of caffeine per day.You have a significant abnormality in your blood count, liver, kidney, or metabolic tests.I am between 18 and 48 years old and have normal sleep patterns.You sleep between 9:00 PM and 8:00 AM.I have been diagnosed with a sleep disorder.You do not smoke or use nicotine products.You have taken opioids prescribed for pain for a long time.I have been exposed to high levels of radiation before this study.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep Continuity Disruption
- Group 2: Sleep Fragmentation
- Group 3: Undisturbed Sleep
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sleep Disorders Patient Testimony for trial: Trial Name: NCT04299490 — Phase 2
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