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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