Sleep DisorderPhase 2Sleep-MORNCT04299490
Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug
A Phase 2 study testing Sleep Fragmentation, Sleep Continuity Disruption and Undisturbed Sleep in people with Sleep Disorder and Healthy, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Healthy
- What is being tested?
- Sleep Fragmentation, Sleep Continuity Disruption and Undisturbed Sleep
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2020to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: Effects of Experimental Sleep Disruption and Fragmentation on Study Drug Receptor Function, Receptor Agonist Analgesia, and Abuse Liability
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.
Read the detailed description
Based on preclinical data and preliminary studies, the investigators hypothesize that sleep continuity disruption (SCD) and/or sleep fragmentation (SF), two sleep patterns commonly observed in both chronic pain and substance use disorders, will alter study drug receptor availability in descending pain inhibitory and reward processing pathways. The investigators further hypothesize that these forms of sleep disruption will increase risk by reducing analgesic efficacy and/or enhancing standard abuse liability measures.
The investigators will conduct a parallel group experiment that will randomize 100 healthy subjects to two nights of either experimental:
- SCD (frank, prolonged, nightly awakenings with curtailed sleep duration, a pattern associated with insomnia);
- SF (multiple, frequent, non-waking arousals with preserved sleep duration, a pattern observed in sleep apnea); or
- undisturbed sleep (US). Subjects will then complete a Carfentanil positron emission tomography (PET) brain imaging scan divided into two phases (resting to measure basal receptor binding potential (BP) and during pain to quantify endogenous medication release). The investigators will then use a placebo-controlled, multiple dose paradigm to evaluate the analgesic efficacy and abuse liability of a study medication. Analgesic efficacy and abuse liability will be evaluated using quantitative sensory testing and standard procedures.
Establishing whether common and treatable forms of sleep disturbance directly alter cerebral receptor availability, analgesia and abuse liability will transform the understanding of how sleep disturbance is a risk factor for substance use disorder and chronic pain and lead to novel prevention efforts and changes in pain management practice.
Objectives:
AIM 1: To evaluate whether experimental SCD and/or SF alter(s) basal (resting) or pain evoked binding potentials (BP) in brain regions associated with descending pain inhibition [dorsolateral prefrontal cortex (DLPFC), anterior cingulate cortex, amygdala, insula, periaqueductal gray, and nucleus accumbens].
H1. Compared to US, SCD and SF will demonstrate altered basal BP in regions of interest.
H2. Compared to US, SCD and SF will demonstrate a blunted release of endogenous drug response (basal BP- pain evoked BP).
AIM 2: To examine whether experimental SCD and/or SF alters the analgesic response and abuse liability profile of a study medication.
H3. Compared to US, SCD and SF will diminish analgesia. H4. Compared to US, SCD and SF will increase drug high, "liking" and monetary valuation of the study medication.
AIM 3: To determine whether BPs in brain regions of interest are associated with analgesia and abuse liability and evaluate the extent to which associations differ by sleep condition or sex.
Study Design:
Participation in this study involves three visits which are completed in approximately 6 weeks. The first visit is a screening visit, where participants will fill out standardized questionnaires to assess medical and psychiatric history as well as sleep patterns. Participants will also receive a physical exam and will undergo blood testing to verify participants' health status. Participants will also be trained to use a sleep diary and devices to monitor participants' sleep at home. If the participant is still eligible, the participant will be asked to come back for a second screening visit which occurs at least one week after the first. At the second visit, sleep monitoring data will be reviewed and the participant will be introduced to the investigators' quantitative sensory testing procedures. Participants will be stimulated by heat, pressure, and cold water to assess baseline estimates of pain severity and unpleasantness. Participants will then undergo the investigators' study drug administration process, where up to three injections will be given that may contain either a drug or a placebo. Throughout this process, quantitative sensory testing will be done to assess analgesic response and questionnaires will be given to assess abuse liability.
If participants remain eligible, the participants will be asked to come for a third visit and spend four consecutive nights and days at the investigators' clinical research unit. Throughout participants' visit, participants will be completing standardized questionnaires and undergoing quantitative sensory testing. Participants will be randomized to undergo either sleep fragmentation, sleep continuity disruption, or undisturbed sleep on nights 2 and 3. On the third day, participants will have a 90 minute PET scan and will undergo a study drug administration procedure similar to what was done in the second screening visit. Participants will then stay for a fourth night of undisturbed sleep and will be discharged the following morning.
- Conditions
- Sleep Disorder, Healthy
- Being tested
- Sleep Fragmentation, Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo), Sleep Continuity Disruption, Undisturbed Sleep
- Keywords
- Insomnia, Sleep Apnea, Sleep disturbances, Pain, Analgesia, Drug Abuse Liability
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes, Parasomnias, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep FragmentationBehavioural
Subjects are provided an 8-hour sleep opportunity. Two speakers are placed 12 inches from the head of the bed and four remote-activated mechanical vibrators are placed underneath the mattress. EEG microarousals (>3 s), as defined according to standard criteria, are elicited at a frequency of 30 or more events per hour.
Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo)Drug
On the third day of the in-patient visit participants will undergo multiple injections of study medication or placebo. This is a double-blind within-subject Phase II trial. As such, study medications must remain blinded. Participants may receive a medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter pain medications, or placebo (saline).
Sleep Continuity DisruptionBehavioural
An 8-hour sleep opportunity period starting from lights out is divided into eight, one-hour intervals. One of the intervals is randomly determined to be a 60 minute forced awakening, during which no sleep is permitted. Each of the remaining seven, 60-minute intervals are subdivided into tertiles (20 min. blocks). A 20-min forced awakening (FA) is randomly scheduled to occur in either the 1st, 2nd, or 3rd tertile of each hour. During FAs, staff keep subjects awake, either by voice or gentle shaking.
Undisturbed SleepBehavioural
Subjects sleep normally for an 8 hour period.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Continuity Disruption | Experimental | 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. Receives: Drug: Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo); Behavioral: Sleep Continuity Disruption |
| Sleep Fragmentation | Experimental | 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. Receives: Behavioral: Sleep Fragmentation; Drug: Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo) |
| Undisturbed Sleep | Active comparator | An 8-hour period of undisturbed sleep is permitted on each night. Receives: Drug: Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo); Behavioral: Undisturbed Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in receptor binding potential from PET scan
The primary dependent measures are the percent change in binding potential of study PET ligand during basal (first 45 minutes) and pain conditions (second 45 minutes) in brain regions of interest. Percent change in binding potential will be assessed between first and second 45 minutes of the 90 minutes assessment session.
Measured: Up to 90 minutes on Day 3 of inpatient visit
Withdrawal Latency measured in seconds during Cold Pressor Pain Tolerance test
The primary measure of study drug analgesia is Cold Pain Threshold withdrawal latency, measured in seconds during the drug administration process. Subjects will immerse their non-dominant hand in a circulating, cold water bath for as long as possible according to standard procedures. The difference in time from when participants first feel pain to when withdraw their hand is recorded as the withdrawal latency.
Measured: Up to 270 minutes post-medication administration
Drug Effects as assessed by the Visual Analog Scale
Drug abuse liability will be assessed with standard visual analog scales (VAS) using a 100-mm line marked at either end with "none"(0) and "extremely" (100).
Measured: Up to 270 minutes post-medication administration
The monetary valuation in dollars of the study medication as assessed by the Drug or Money Multiple Choice Questionnaire
The Monetary Valuation of the study medication will be assessed with the Drug or Money Multiple Choice Questionnaire, commonly used in abuse liability testing. Participants indicate on a sliding scale a monetary value (range $0 to "more than $30") above which they would prefer money and below which they would prefer the drug.
Measured: 150 minutes after final dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start11 Nov 2020
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Eric C Strain, MD, Study chair, Johns Hopkins UniversityNaresh Punjabi, MD, Study chair, Johns Hopkins UniversityClaudia Campbell, PhD, Study chair, Johns Hopkins UniversityPatrick H Finan, PhD, Study chair, Johns Hopkins UniversityJeannie Leoutsakos, PhD, Study chair, Johns Hopkins UniversityHiroto Kuwabara, MD, Study chair, Johns Hopkins UniversityAlexandra Kearson, BA, Study chair, Johns Hopkins UniversityMichael T Smith, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299490
- Sponsor's protocol ID
- IRB00224309
- Other IDs
- 1U01HL150568-01
- Acronym
- Sleep-MOR
- Status last verified
- Sep 2025
- First submitted
- 3 Mar 2020
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Experimental Sleep Disruption and Fragmentation on Study Drug Receptor Function, Receptor Agonist Analgesia, and Abuse Liability
- ClinicalTrials.gov ID
- NCT04299490
- Acronym / sponsor ID
- Sleep-MOR / IRB00224309
- Conditions
- Sleep Disorder, Healthy
- Keywords
- Insomnia, Sleep Apnea, Sleep disturbances, Pain, Analgesia, Drug Abuse Liability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Based on preclinical data and preliminary studies, the investigators hypothesize that sleep continuity disruption (SCD) and/or sleep fragmentation (SF), two sleep patterns commonly observed in both chronic pain and substance use disorders, will alter study drug receptor availability in descending pain inhibitory and reward processing pathways. The investigators further hypothesize that these forms of sleep disruption will increase risk by reducing analgesic efficacy and/or enhancing standard abuse liability measures.
The investigators will conduct a parallel group experiment that will randomize 100 healthy subjects to two nights of either experimental:
- SCD (frank, prolonged, nightly awakenings with curtailed sleep duration, a pattern associated with insomnia);
- SF (multiple, frequent, non-waking arousals with preserved sleep duration, a pattern observed in sleep apnea); or
- undisturbed sleep (US). Subjects will then complete a Carfentanil positron emission tomography (PET) brain imaging scan divided into two phases (resting to measure basal receptor binding potential (BP) and during pain to quantify endogenous medication release). The investigators will then use a placebo-controlled, multiple dose paradigm to evaluate the analgesic efficacy and abuse liability of a study medication. Analgesic efficacy and abuse liability will be evaluated using quantitative sensory testing and standard procedures.
Establishing whether common and treatable forms of sleep disturbance directly alter cerebral receptor availability, analgesia and abuse liability will transform the understanding of how sleep disturbance is a risk factor for substance use disorder and chronic pain and lead to novel prevention efforts and changes in pain management practice.
Objectives:
AIM 1: To evaluate whether experimental SCD and/or SF alter(s) basal (resting) or pain evoked binding potentials (BP) in brain regions associated with descending pain inhibition [dorsolateral prefrontal cortex (DLPFC), anterior cingulate cortex, amygdala, insula, periaqueductal gray, and nucleus accumbens].
H1. Compared to US, SCD and SF will demonstrate altered basal BP in regions of interest.
H2. Compared to US, SCD and SF will demonstrate a blunted release of endogenous drug response (basal BP- pain evoked BP).
AIM 2: To examine whether experimental SCD and/or SF alters the analgesic response and abuse liability profile of a study medication.
H3. Compared to US, SCD and SF will diminish analgesia. H4. Compared to US, SCD and SF will increase drug high, "liking" and monetary valuation of the study medication.
AIM 3: To determine whether BPs in brain regions of interest are associated with analgesia and abuse liability and evaluate the extent to which associations differ by sleep condition or sex.
Study Design:
Participation in this study involves three visits which are completed in approximately 6 weeks. The first visit is a screening visit, where participants will fill out standardized questionnaires to assess medical and psychiatric history as well as sleep patterns. Participants will also receive a physical exam and will undergo blood testing to verify participants' health status. Participants will also be trained to use a sleep diary and devices to monitor participants' sleep at home. If the participant is still eligible, the participant will be asked to come back for a second screening visit which occurs at least one week after the first. At the second visit, sleep monitoring data will be reviewed and the participant will be introduced to the investigators' quantitative sensory testing procedures. Participants will be stimulated by heat, pressure, and cold water to assess baseline estimates of pain severity and unpleasantness. Participants will then undergo the investigators' study drug administration process, where up to three injections will be given that may contain either a drug or a placebo. Throughout this process, quantitative sensory testing will be done to assess analgesic response and questionnaires will be given to assess abuse liability.
If participants remain eligible, the participants will be asked to come for a third visit and spend four consecutive nights and days at the investigators' clinical research unit. Throughout participants' visit, participants will be completing standardized questionnaires and undergoing quantitative sensory testing. Participants will be randomized to undergo either sleep fragmentation, sleep continuity disruption, or undisturbed sleep on nights 2 and 3. On the third day, participants will have a 90 minute PET scan and will undergo a study drug administration procedure similar to what was done in the second screening visit. Participants will then stay for a fourth night of undisturbed sleep and will be discharged the following morning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleep Continuity Disruption | Experimental | Drug: Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo), Behavioral: Sleep Continuity DisruptionThe 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. |
| Sleep Fragmentation | Experimental | Behavioral: Sleep Fragmentation, Drug: Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo)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. |
| Undisturbed Sleep | Active comparator | Drug: Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo), Behavioral: Undisturbed SleepAn 8-hour period of undisturbed sleep is permitted on each night. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.).
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep FragmentationSubjects are provided an 8-hour sleep opportunity. Two speakers are placed 12 inches from the head of the bed and four remote-activated mechanical vibrators are placed underneath the mattress. EEG microarousals (>3 s), as defined according to standard criteria, are elicited at a frequency of 30 or more events per hour. | Behavioural | Sleep Fragmentation |
| Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo)On the third day of the in-patient visit participants will undergo multiple injections of study medication or placebo. This is a double-blind within-subject Phase II trial. As such, study medications must remain blinded. Participants may receive a medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter pain medications, or placebo (saline). | Drug | Sleep Continuity Disruption, Sleep Fragmentation, Undisturbed Sleep |
| Sleep Continuity DisruptionAn 8-hour sleep opportunity period starting from lights out is divided into eight, one-hour intervals. One of the intervals is randomly determined to be a 60 minute forced awakening, during which no sleep is permitted. Each of the remaining seven, 60-minute intervals are subdivided into tertiles (20 min. blocks). A 20-min forced awakening (FA) is randomly scheduled to occur in either the 1st, 2nd, or 3rd tertile of each hour. During FAs, staff keep subjects awake, either by voice or gentle shaking. | Behavioural | Sleep Continuity Disruption |
| Undisturbed SleepSubjects sleep normally for an 8 hour period. | Behavioural | Undisturbed Sleep |
Primary outcome
Percent change in receptor binding potential from PET scan
Time frame: Up to 90 minutes on Day 3 of inpatient visit
The primary dependent measures are the percent change in binding potential of study PET ligand during basal (first 45 minutes) and pain conditions (second 45 minutes) in brain regions of interest. Percent change in binding potential will be assessed between first and second 45 minutes of the 90 minutes assessment session.
Withdrawal Latency measured in seconds during Cold Pressor Pain Tolerance test
Time frame: Up to 270 minutes post-medication administration
The primary measure of study drug analgesia is Cold Pain Threshold withdrawal latency, measured in seconds during the drug administration process. Subjects will immerse their non-dominant hand in a circulating, cold water bath for as long as possible according to standard procedures. The difference in time from when participants first feel pain to when withdraw their hand is recorded as the withdrawal latency.
Drug Effects as assessed by the Visual Analog Scale
Time frame: Up to 270 minutes post-medication administration
Drug abuse liability will be assessed with standard visual analog scales (VAS) using a 100-mm line marked at either end with "none"(0) and "extremely" (100).
The monetary valuation in dollars of the study medication as assessed by the Drug or Money Multiple Choice Questionnaire
Time frame: 150 minutes after final dose administration
The Monetary Valuation of the study medication will be assessed with the Drug or Money Multiple Choice Questionnaire, commonly used in abuse liability testing. Participants indicate on a sliding scale a monetary value (range $0 to "more than $30") above which they would prefer money and below which they would prefer the drug.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sleep Fragmentation, Sleep Continuity Disruption and Undisturbed Sleep in people with Sleep Disorder and Healthy, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in receptor binding potential from PET scan (time frame: Up to 90 minutes on Day 3 of inpatient visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.