Effects of Sleep Disruption on Drug Response

Launched by JOHNS HOPKINS UNIVERSITY · Sep 20, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at how sleep disruption affects how people respond to medications, particularly focusing on those with chronic low back pain (CLBP) compared to healthy individuals. Researchers want to understand whether a lack of sleep changes how much people like the medication and how well it helps with pain. They will be conducting a study where participants will receive either the actual medication or a placebo (a harmless substitute) after one good night’s sleep and then again after a night of disrupted sleep. They aim to recruit both patients with chronic low back pain and healthy volunteers to see how their responses differ.

To participate, individuals need to be between 18 and 60 years old, consume less than two caffeinated drinks per day, and be willing to stop caffeine for three days before joining. For those with chronic low back pain, a doctor must confirm their condition. However, there are several reasons someone might not be eligible, including certain medical conditions or current use of specific medications. Participants in the trial can expect to go through a series of tests to measure their reactions to the medication and pain, helping researchers learn more about how sleep influences pain treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• General Inclusion Criteria:
• • 18-60 years old
• • Less than 2 servings/day of caffeinated beverages and willing to discontinue 3 days prior to admission.
• CLBP-Specific Inclusion Criteria:
• • Have a physician-confirmed diagnosis of CLBP
• • Report chronic low back pain.
• Exclusion Criteria:
• General Exclusion Criteria:
• • BMI \>40
• • Significant medical or psychiatric morbidity within 6 months or lifetime history of bipolar disorder, psychotic disorder, seizure disorder
• • Lifetime history of opioid use disorder
• • Clinically significant abnormal complete blood count or comprehensive metabolic profile
• • Any contraindicated medical condition (status asthmaticus; chronic obstructive pulmonary disease; reduced respiratory function; hypotension; hypertension; impairment of hepatic, pulmonary or renal functions; myxedema or hyperthyroidism; adrenocortical insufficiency; gastrointestinal obstruction; gall bladder disease; acute alcoholism; history of convulsive disorders; history of head injury)
• • Current use of stimulants, opioids, benzodiazepines or other Central Nervous System (CNS) depressant
• • Positive toxicology screen for opioids, stimulants, or recreational drugs
• • Pregnancy or lactation
• • Significant preadmission psychological distress.
• Healthy Control and CLBP-Specific Exclusion Criteria:
• • Report current medical/psychiatry history
• • Report acute painful injury (within 3 months)
• • Have a diagnosed chronic pain disorder.