Skip to main content

Table 2 Schedule of events during experimental day

From: FORWARDS-1: an adaptive, single-blind, placebo-controlled ascending dose study of acute baclofen on safety parameters in opioid dependence during methadone-maintenance treatment—a pharmacokinetic-pharmacodynamic study

Procedure

Time point (min post-baclofen/placebo)

aBaseline

15

30

60

90

120

180

240

300

NEWS2

x

x

x

x

x

x

SpO2

x

xb

xb

x

xb

x

x

x

x

RR

x

xb

xb

x

xb

x

x

x

x

BP

x

x

x

x

x

x

HR

x

x

x

x

x

x

Body temperature

x

x

x

x

x

x

LOC

x

x

x

x

x

x

GCS

x

x

x

x

x

x

ECG

x

x

x

tcCO2

x

x

x

x

x

x

x

x

x

SHAS

x

x

x

x

x

x

DEQ

x

x

x

x

x

x

VAS craving/anxiety

x

x

x

x

x

x

Blood plasma/serum

x

x

x

x

x

COWS

x

x

x

  1. RR respiratory rate, BP blood pressure, HR heart rate, LOC level of consciousness
  2. aBaseline refers to the measurements obtained prior to time 0, which represents the time at which baclofen/placebo is administered. Shaded areas are measures comprising the NEWS2 score
  3. bAt these time points, SpO2 and RR measures will be taken in addition to those associated with the NEWS2