Table 1.
Schedule of events
| 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 |