Buckman 2015.
Study characteristics | ||
Methods | Randomised controlled trial, parallel‐group assignment, open‐label study | |
Participants | 72 healthy participants with average age of 21.7 years (SD = 0.9). Among participants, 44% were female Exclusion criteria:
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Interventions |
Each beverage was divided into 3 equal drinks, and participants were instructed to consume each beverage evenly over a 5‐minute period (total drinking time = 15 minutes) |
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Outcomes |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Participants were randomly assigned to the alcohol, placebo, or no‐alcohol beverage group” "Upon arrival in the laboratory, weight, height, pregnancy status, and a zero blood alcohol concentration (BAC) were confirmed and participants were randomly assigned to the alcohol, placebo, or no‐alcohol beverage group, as described below" "Table 1 shows that groups were not statistically different in terms of demographics, family history of alcohol dependence, alcohol use, and mood" Comment ‐ adequate randomisation was probably done and baseline characteristics between groups were well matched |
Allocation concealment (selection bias) | Unclear risk | Comment ‐ method of allocation concealment was not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | “Participants in the alcohol group (n = 24) were told that they would receive some amount of alcohol and were given mixer (orange, cranberry, and lime juice) with an active ethanol…” “Participants in the placebo group (n = 24) were told that they would be given some amount of alcohol and received mixer with a physiologically inactive dose of alcohol…” “The no‐alcohol control group (n = 24) were told that they would not be given alcohol and received 100% mixer” Comment ‐ study was not blinded for participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment ‐ study was not blinded for outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment ‐ all participants were included in the final analysis (additional information from study author) |
Selective reporting (reporting bias) For systolic blood pressure (SBP) | Low risk | Comment ‐ study authors reported SBP and SD |
Selective reporting (reporting bias) For diastolic blood pressure (DBP) | High risk | Comment ‐ study authors did not report DBP |
Selective reporting (reporting bias) For mean arterial blood pressure (MAP) | Low risk | Comment ‐ study authors reported MAP and SD |
Selective reporting (reporting bias) For heart rate (HR) | Low risk | Comment ‐ study authors reported HR and SD |
Other bias (conflict of interest, industry sponsorship) | Low risk | "This study was funded with the support of K01AA017473, K02AA00325, K24AA021778, R21AA020367, and HHSN275201000003C" |
Other bias (was the study registered in clinical trials.gov/ was the protocol available?) | High risk | Comment ‐ protocol was not registered and study identifier was not reported |