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. 2015 Nov 12;2015(11):CD009464. doi: 10.1002/14651858.CD009464.pub2

Chang 1979a.

Study characteristics
Methods Randomised, double‐blind, 3‐period cross‐over, placebo‐controlled trial
Participants 15 people (10/15 (67%) men/5/15 (33%) women) aged 15‐49 years (median = 24 years). 4/15 (27%) participants were cannabis naive
Tumour type: osteogenic sarcoma
Chemotherapy regimens: methotrexate 250 mg/kg with leucovorin calcium rescue every 3 weeks for 18 months
Chemotherapy emetogenicity: low
Interventions Dronabinol 10 mg/m2 orally every 3 hours for total 5 doses (Phase I), n = 15.
If participant vomited during this period oral dose was replaced with THC cigarette for remaining doses
Placebo, n = 15
Outcomes Episodes of nausea and vomiting on day of therapy; frequency and severity of nausea; episodes of sedation, euphoria, dizziness, depression, paranoia
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Order of THC‐placebo administration was randomized into three paired trials"
Allocation concealment (selection bias) Unclear risk Not reported
Incomplete outcome data (attrition bias)
All outcomes High risk 58/77 (75%) participants received THC, 39/53 (74%) participants received placebo
Selective reporting (reporting bias) Low risk Data reported for primary outcome
Other bias Low risk Groups balanced at baseline
Blinding of participants and personnel (performance bias)
All outcomes Low risk "Identical gelatin capsules with sesame oil". "Identical cigarettes, the odour and taste of a lit placebo cigarette were identical to those of cannabis cigarette"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinding assumed as study reported as "double‐blind"