Abstract
Background. Despite a clear market need and many hangover products available, currently there is no hangover treatment that is supported by substantial scientific evidence demonstrating its efficacy and safety. A pilot study was conducted to investigate the effects of a potential new hangover treatment, SJP-001, and its constituents (220 mg naproxen and 60 mg fexofenadine) on hangover severity. Methods. N = 13 healthy social drinkers (36.3 ± 8.9 years old) participated in a double-blind, factorial design, cross-over study. On each test day, they consumed their own choice of alcohol up to a self-reported level sufficient to elicit a next-day hangover. Treatments were administered prior to onset of drinking. Next morning, hangover severity was assessed with the Acute Hangover Scale (AHS). Subjects were included in the efficacy analysis only if they reported a hangover after placebo. Results. N = 5 subjects (60% male, 35.2 ± 9.0 years old) were included in the analysis. They consumed a mean (SD) of 4.6 ± 1.1 units of alcohol and had an average peak breath alcohol concentration (BrAC) of 0.065% across conditions. Compared to placebo, SJP-001 significantly improved the AHS overall hangover severity score (0.8 ± 0.3 versus 1.5 ± 0.9, p = 0.042). Compared to placebo, SJP-001 also reduced scores on the individual item ‘hangover’, although the observed improvement (−1.6) did not reach statistical significance (p = 0.102). The differences from placebo after naproxen alone and fexofenadine alone were not statistically significant. SJP-001 also improved scores for the individual hangover symptoms tired, thirsty, headache, dizziness, nausea, and loss of appetite, but these effects did not reach statistical significance. Discussion. Compared to placebo, SJP-001 significantly reduced overall hangover severity. The effects of SJP-001 should be further examined in a double-blind, placebo-controlled trial with a larger sample size and controlled administration of sufficient amounts of alcohol to provoke a more substantial alcohol hangover.
Highlights
The alcohol hangover is defined as “the combination of negative mental and physical symptoms which can be experienced after a single episode of alcohol consumption, starting when blood alcohol concentration (BAC) approaches zero” [1,2]
The findings of the current pilot study suggest that SJP-001 may be effective in the prevention of alcohol hangover
The observations should be interpreted with caution, as this pilot study had a small sample size
Summary
The alcohol hangover is defined as “the combination of negative mental and physical symptoms which can be experienced after a single episode of alcohol consumption, starting when blood alcohol concentration (BAC) approaches zero” [1,2]. Alcohol hangovers are typically characterized by a combination of symptoms, affecting mood, cognition, and physical functioning [5,6,7,8] These negatively impact daily activities including, but not restricted to, job performance [9] and driving [10,11,12]. A pilot study was conducted to investigate the effects of a potential new hangover treatment, SJP-001, and its constituents (220 mg naproxen and 60 mg fexofenadine) on hangover severity. N = 5 subjects (60% male, 35.2 ± 9.0 years old) were included in the analysis They consumed a mean (SD) of 4.6 ± 1.1 units of alcohol and had an average peak breath alcohol concentration (BrAC) of 0.065% across conditions. SJP-001 significantly improved the AHS overall hangover severity score (0.8 ± 0.3 versus 1.5 ± 0.9, p = 0.042). The effects of SJP-001 should be further examined in a double-blind, placebo-controlled trial with a larger sample size and controlled administration of sufficient amounts of alcohol to provoke a more substantial alcohol hangover
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