Event | Screening | Enrolment | Experimental | Follow-up |
---|---|---|---|---|
General | ||||
Consent and eligibility | x | x | ||
General health | x | x | x | |
Demographics | x | |||
Clinical assessments | ||||
Structured clinical interview (MINI) | x | |||
Medical examination | x | |||
Vital statistics (height, weight) | x | |||
Vital signs (BP, HR, SpO2) | x | x | ||
Respiratory function | x | x | ||
Blood sampling (clinical) | (x) | |||
Urine screen (DOA and pregnancy) | x | x | ||
Breath alcohol | x | x | ||
Methadone administration | x | |||
Baclofen or Placebo administration | x | |||
Drug and alcohol history | ||||
Methadone dose check | x | x | ||
TLFB (drug and alcohol use) | x | |||
FTND | x | |||
AUDIT | x | |||
ASSIST (shortened) | x | |||
SDS | x | |||
OCDUS-H | x | |||
Randomisation | ||||
Randomisation and enrolment | x | |||
Mood, sleep, and personality | ||||
BDI | x | |||
STAI | x | |||
PSQI | x | |||
RLS Scale | x | |||
STOP-BANG | x | |||
ESS | x | |||
State measures | ||||
VAS drug effects (SHAS, DEQ) | x | |||
VAS craving, anxiety | x | x | ||
COWS | x | x | ||
LSEQ, sleep quality | x | x | ||
Adverse events | x | x | ||
Blood measures | ||||
Growth hormone | x | |||
Baclofen/methadone | x | |||
Actigraphy measures | ||||
Actigraphy/SpO2 finger monitor | x | (x) | x | x |