Effects of sleep disturbances on drug receptor function
Effects of Experimental Sleep Disruption and Fragmentation on Study Drug Receptor Function, Receptor Agonist Analgesia, and Abuse Liability
This study is testing how sleep problems affect brain receptors and the pain relief from a medication in healthy people.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04299490 on ClinicalTrials.gov |
What this trial studies
This project aims to investigate how common sleep disturbances, specifically sleep continuity disruption and sleep fragmentation, affect the availability of drug receptors in the brain and the efficacy of a study medication for pain relief. The study will involve 100 healthy participants who will be randomized to experience either sleep disturbances or undisturbed sleep over two nights. Following this, participants will undergo brain imaging to assess receptor binding and will participate in tests to evaluate the analgesic effects and potential for abuse of the medication. The study will also explore how these effects may vary based on sleep condition and sex.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-48 with normal sleep patterns.
Not a fit: Patients with chronic pain or significant sleep disorders are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for individuals with sleep disturbances.
How similar studies have performed: While the specific approach of this study is novel, related research has indicated that sleep disturbances can impact pain perception and medication efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Michael T Smith, PhD — Johns Hopkins University
- Study coordinator: Michael T Smith, PhD
- Email: msmith62@jhmi.edu
- Phone: 4105507000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.