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Sleep Disruption's Impact on Medication Efficacy for Lower Back Pain
Study Summary
This trial will study the effects of sleep disruption on CLBP patients' and healthy controls' subjective responses to study medication administration, with a focus on two outcome domains: abuse liability and response to pain testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You drink less than 2 servings of caffeinated drinks per day and are willing to stop drinking them for 3 days before the study.You have abnormal results on blood and metabolic tests that are important for your health.I do not have severe asthma, lung, liver, kidney problems, thyroid issues, adrenal gland issues, stomach blockage, gallbladder disease, severe alcoholism, a history of seizures or head injuries.You are experiencing significant emotional distress before joining the trial.I do not have a diagnosed chronic pain disorder.You drink less than 2 servings of caffeinated drinks each day and are willing to stop drinking them for 3 days before the study starts.I have chronic low back pain.My doctor has diagnosed me with chronic lower back pain.I am between 18 and 60 years old.I have not had serious health or mental health issues in the last 6 months and do not have a history of bipolar, psychosis, or seizures.I have no current significant medical or psychiatric conditions.I have not had a painful injury in the last 3 months.You have a body mass index (BMI) greater than 40.I am between 18 and 60 years old.I have been diagnosed with chronic lower back pain by a doctor.I am not currently using stimulants, opioids, benzodiazepines, or other CNS depressants.You have tested positive for opioids, stimulants, or recreational drugs.My condition specifically relates to chronic lower back pain.I have chronic low back pain.
- Group 1: Uninterrupted Sleep
- Group 2: Sleep Disruption
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Who has been qualified to participate in this trial?
"This medical experiment allows for enrolment of those aged between 18 and 60 years old. Approximately 250 individuals will be admitted in total."
What is the aim of this research endeavor?
"The major end point of this trial, assessed over a period of up to 7 hours post-medication administration, is the Heat Pain Threshold. Other outcomes being monitored include Level of "Highness" rated on Visual Analog Scale (VAS) with 0 signifying None and 100 Extremely; Clinical Pain also evaluated via VAS with 0 denoting No Pain and 100 Worst Pain Imaginable; as well as Good Drug Effects determined by another VAS rating where 0 corresponds to None and 100 stands for Extremely."
Does this research program admit individuals older than twenty-five years?
"The minimum age requirement for this medical trial is 18 while the upper limit is set at 60. There are 61 seperate studies available to those younger than 18 and 590 that are specifically designed for elderly patients over 65 years old."
What is the current participant total for this medical experiment?
"Affirmative. Perusal of the clinicaltrials.gov website reveals that this study, initially posted on October 7th 2019, is still open for recruitment. The current goal is to enroll 250 volunteers at a single site."
What potential harms can be encountered when taking part in a Within-Subject test of blinded study medication?
"Our evaluative committee at Power gave Within-Subject test of blinded study medication a score of 2, as the Phase 2 trial has provided evidence that it is safe but not yet proven to be efficacious."
Are there currently any enrollment opportunities for this research?
"According to the details on clinicaltrials.gov, this medical trial remains open to applicants with its inception dating back to October 7th 2019 and a recent update taking place on January 10th 2022."
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