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Table 3 Timeline of assessments

From: Comparing rapid micro-induction and standard induction of buprenorphine/naloxone for treatment of opioid use disorder: protocol for an open-label, parallel-group, superiority, randomized controlled trial

Assessments

Screening

Randomization

Baselined

Day 1d

Day 2

Day 3

Day 4

Day 7

Experimental arm: rapid micro-induction

(E stands for experimental arm assessments)

   

 

Control arm: standard induction

(C stands for control arm assessments)

   

  

Informed consent form

E

C

       

Physical examination

E

C

 

E

C

E

C

E

C

E

C

E

 

Medical history

E

C

       

Pregnancy test

E

C

       

Blood testsa

E

C

       

Viral profileb

E

C

       

Urine drug screens

E

C

 

E

C

 

C

E

  

Opiate treatment index (OTI)—health section

  

E

C

     

Treatment outcomes profile (TOP)

  

E

C

 

C

E

  

Clinical Opiate Withdrawal Scale (COWS)

  

Ec

Cc

Ec

Cc

Ec

   

Numeric Rating Scale for craving

  

Ec

Cc

Ec

Cc

Ec

   

Numeric Rating Scale for pain

  

Ec

Cc

Ec

Cc

Ec

   

Treatment Perceptions Questionnaire (TPQ)

    

C

E

  

Assessment of treatment retention

       

E

C

Adverse event report form

  

E

C

E

C

E

C

E

C

E

 
  1. aComplete blood count (CBC), Extended lytes, Liver function
  2. bHepC serology, HepB antigen, HIV Elisa
  3. cThe COWS and Numeric Rating Scales for craving and pain will be administered at baseline, every 1.5 h during the abstinence period (control arm only), and throughout the induction process for both arms (days 1 to 2 of the experimental arm, and day 1 of the control arm)—specifically, immediately before each dose of buprenorphine/naloxone, and 1 to 1.5 h after each dose of buprenorphine/naloxone
  4. dBaseline and day 1 assessments may be done on the same day, depending on the time of day the participants are recruited in the study and the state they are in when they are recruited