Effects of Sleep Disruption on Drug Response

NCT03680287 PHASE2 COMPLETED

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.

Details

Lead sponsor	Johns Hopkins University
Phase	PHASE2
Status	COMPLETED
Enrolment	109
Start date	Mon Oct 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Low Back Pain, Recurrent
• Healthy

Interventions

• Within-Subject test of blinded study medication

Countries

United States