Effects of Sleep Disruption on Drug Response (NCT03680287) | Clinical Trial Compass
CompletedPhase 2
Effects of Sleep Disruption on Drug Response
United States109 participantsStarted 2019-10-07
Plain-language summary
The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy controls, and that sex will moderate effects.
The proposed study evaluates whether CLBP patients' subjective responses to study medication administration are altered by SD. The investigators focus on two outcome domains: abuse liability (i.e., drug liking and valuation) and response to pain testing.
The investigators propose a mixed between-within randomized crossover human-laboratory experiment that investigates placebo-controlled effects of study medication on 1) abuse liability metrics (Drug Liking and Monetary Valuation) and 2) response to laboratory-evoked standardized pain measures, after one night of uninterrupted sleep (US) and again after one night of SD. The investigators will recruit both CLBP patients(\*) and healthy controls (N = 60).
(\*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by the National Institute on Drug Abuse (NIDA) to reduce expectations for the target N for the CLBP cohort. We are no longer expected to recruit N=60 CLBP participants; this is a COVID-19 modification, and we are not required to re-do a power analysis.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drug Liking as assessed by the Visual Analog Scale
Timeframe: up to 420 minute post-medication administration
2
Heat Pain Threshold
Timeframe: up to 420 minute post-medication administration
3
Suprathreshold Tonic Heat Pain
Timeframe: up to 420 minute post-medication administration
4
Monetary Valuation of Drug as assessed by the Drug vs. Money Multiple Choice Questionnaire
Timeframe: up to 420 minute post-medication administration