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Table 1 Schedule of events

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

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