Clinical Trial

Effects of Sleep Disruption on Drug Response

Study Description

Effects of Sleep Disruption on Drug Response

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 (N = 60) and healthy controls (N = 60).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Within-Subject test of blinded study medication

On the day after each sleep condition (Uninterrupted Sleep and Sleep Disruption), 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 medications, or placebo (saline). ...read more on ClinicalTrials.org

Additional Information

Official Study Title

Effects of Sleep Disruption on Drug Response

Clinical Trial ID

NCT03680287

ParticipAid ID

dwp0Me