| 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 |