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Table 2 Schedule of trial procedures and assessments

From: A phase III multisite randomised controlled trial to compare the efficacy of cannabidiol to placebo in the treatment of cannabis use disorder: the CBD-CUD study protocol

Assessment/ Procedure

Screening

Intervention Phase

Follow-up

Week

-t1

1

4

7

10

13

25

ENROLMENT

 Phone screen (eligibility)

X

      

 Medical screen/assessment (eligibility)a

X

      

 Urine drug screen and βhcG

X

      

 Blood test (LFTs)

X

      

 Informed consent

 

X

     

 Enrol and Randomisation

 

X

     

INTERVENTION

 Medication [CBD or placebo] dispensed

 

X

X

X

X

  

 Adverse Events Assessmentsb

  

X

X

X

X

 

 Concomitant Medicationsb

  

X

X

X

X

 

 CBT counselling interventionc

  

X

 

X

  

RESEARCH ASSESSMENTS

 Research Interviewsd: Collection of UDS, TLFB, Quantity of Cannabis Use, SUG, Rates of Abstinence, PROMIS-29, Testing of the Blind, CWS, MCQ, ATOP, FTND

 

X

X

X

X

X

X

 DSM-5, PTSD, MPQ

 

X

   

X

X

 TSQM, DEQ-5

  

X

X

X

X

X

 PSIa

 

X

 

X

 

X

X

 Treatment Retention

     

X

 

 Cognitive assessmentse: RAVLT, NART-17, Eriksen Arrow Flankers Task, N-Back, Digit Span Task, TMT

 

X

   

X

 

 Interviews with Indigenous Australian participants + m-EDSf

 

X

 

X

   
  1. aMedical screening to be conducted within 4 weeks of study enrolment on Week 1, Day 1
  2. bAdverse event assessments and concomitant medications are assessed by the study medical officer or clinical nurse specialist
  3. cCognitive behavioural therapy intervention to be conducted by experienced cannabis counsellors. Three sessions to be conducted over the first 6 weeks of treatment and one session between weeks 7–13 of intervention period
  4. dAll research interviews and cognitive assessments will be conducted by the site coordinator. See Table 1 for descriptions of each research measure
  5. eRAVLT: This task assesses verbal learning and memory; NART-17 = National Adult Reading Test: this task assesses pre-morbid IQ; Eriksen Arrow Flankers Flankers: This test assesses both choice reaction time and the ability to ignore distracting but irrelevant information; N-back: this is a working memory task; Digit span task: evaluates working memory; Trail Making Test: assesses attention, processing speed, and cognitive flexibility
  6. fModified Everyday Discrimination Scale (m-EDS) will be conducted at Week 1 baseline and a qualitative research interview with consenting Indigenous Australians will be conducted by the study’s Aboriginal Research Coordinator between weeks 7–13