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Table 1 Table of schedule of events

From: Randomised Controlled Trial (RCT) of cannabinoid replacement therapy (Nabiximols) for the management of treatment-resistant cannabis dependent patients: a study protocol

 

Study period

Screen

Enrol

Post-allocation

Follow up

Timepoint*

-t1

0

Wk 1

Wk2

Wk3

Wk4

Wk5

Wk6

Wk7

Wk8

Wk9

Wk

10

Wk

11

Wk

12

Wk

13

Wk 24

Enrolment

 Phone screen (Eligibility)

X

               

 Informed consent for medical screen

X

               

 Medical screen/assessment (Eligibility)

X

               

 Informed consent for main study participation

 

X

              

 Allocation

 

X

              

Intervention

 Medication [Nabiximols or placebo] dispensed

  

X

X

X

X

X

X

X

X

X

X

X

X

X

 

 Nursing clinical reviews

  

X

X

X

X

X

X

X

X

X

X

X

X

X

 

 Medical clinical reviews

  

X

X

 

X

   

X

   

X

  

 CBT sessions

   

X

 

X

 

X

 

X

 

X

 

X

  

 Urine drug screen

 

X

X

X

X

X

X

X

X

X

X

X

X

X

 

X

Assessments

 Research Interviews. Variables include:

Cannabis & other substance use (TLFB), CWS, AEs, Aberrant medication behaviour (mod ORBIT), SF-6D (QOL), WHO Health and Performance Questionnaire: CT version, SF-36 (Physical and Mental health), DASS-21, PHQ-15, OTI: BPI, Crime, Satisfaction, Test blind (week 12 only)

 

X

   

X

   

X

   

X

 

X

 Clinical (Nursing/medical) Review variables:

AEs, Aberrant medication behaviour (weigh bottles), ratings dose adequacy, ATOP & BPRS at 4 week intervals, reason for study termination Wk 24.

  

X

X

X

X

X

X

X

X

X

X

X

X

  

 Cognitive assessment. Variables include

Blood samples (pre/post cognitive testing), Cognitive testing, Abuse liability (subjective liking, strength, Physiological response)

 

X

   

X

         

X