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Study Title and Description

Effects of alcohol, coffee, and tobacco, alone or in combination, on physiological parameters and anxiety in a young population



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on behavior*?
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Primary Publication Information
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TitleData
Title Effects of alcohol, coffee, and tobacco, alone or in combination, on physiological parameters and anxiety in a young population
Author C. Vinader-Caerols, S. Monleon, C. Carrasco and A. Parra
Country
Year 2012
Numbers

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Extraction Form: Behavior - Design Details - INCLUDED Studies
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 10499
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What outcome is being evaluated in this paper? Behavior
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What is the objective of the study (as reported by the authors)? The objective of the present research was to evaluate the effects of a single dose of alcohol, caffeine, and nicotine, alone or in combination, on several physiological measures (SBP and diastolic blood pressure [DBP] and HR) and on state-trait anxiety in healthy young volunteers by reproducing the manner in which they are normally consumed by these subjects.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) Subjects Participants were 76 healthy undergraduate students at the Faculty of Psychology, University of Valencia, Spain (12 men and 64 women; numbers were representative of the gender distribution of these students in the Psychology Faculty; mean age: 20.34 – 2.34 years). The volunteers were recruited as experimental subjects for this study according to self-report of their consumption habits and general health. They were distributed as follows: 10 control subjects, 10 smokers ( ‡ 7 cigarettes per day), 10 habitual coffee consumers ( ‡ 1 cup of coffee per day), 10 social consumers of alcohol ( ‡ 3 standard drinks per week), 10 smokers and habitual coffee consumers, 8 smokers and social consumers of alcohol, 9 social consumers of alcohol and habitual coffee consumers, and 9 smokers, habitual coffee consumers, and social consumers of alcohol. Tests and apparatus _x0002_ The State-Trait Anxiety Inventory (STAI) is a questionnaire consisting of 20 items referring to self-reported state anxiety (SA) and 20 items referring to trait anxiety (TA). All subjects completed the standardized Spanish version of the STAI. Procedure According to their consumption habits, subjects were assigned to one of eight experimental treatment groups: Alcohol (A) (15.8 g in women and 18.7 g in men through an alcoholic beverage; these alcohol doses were chosen for every gender following the Widmark formula to obtain similar expected blood alcohol contents); Caffeine (C) (intake of a cup of coffee containing 80.6–86.73mg caffeine, determined using the high performance liquid chromatography technique); Nicotine (N) (the smoking of a cigarette after a minimum period of abstinence of 30 minutes); Caffeine-Nicotine (C-N) (the smoking of a cigarette and intake of a cup of coffee); Alcohol-Nicotine (A-N) (intake of an alcoholic drink and the smoking of a cigarette); Caffeine-Alcohol (C-A) (intake of a cup of coffee and an alcoholic drink); Caffeine-Alcohol-Nicotine (C-A-N) (intake of a cup of coffee and an alcoholic drink and the smoking of a cigarette); and Control group (Co) (no intake). Each subject participated in two phases separated by an interval of 25 minutes: treatment (10 minutes) and waiting time (15 minutes). In the first phase, the physiological parameters of BP and HR were registered in all the subjects. The concentration of CO in the smokers was measured using a co-oximeter and the concentration of alcohol in the social consumers was measured by an alcoholmeter. SA was assessed using the STAI. In the second phase, the same measures were registered, as were TA, the AUDIT for alcoholic dependence in social consumers of alcohol (mean score: 6.5 – 1.08), and the Fagerstrom questionnaire for smokers (mean score: 2.51 – 0.41). All the experimental tests were performed between 10:00 a.m. and 01:00 p.m. [No information was provided as to what the control group did during the 25 minutes between measurements.] Statistics Separate analysis of variances (ANOVAs) were performed for each measure (SBP,DBP,HR, SA, and TA) in each treatment group (A, C, N, C-N, A-N, C-A, and C-A-N) with respect to Co, with two factors: the between-subjects factor ‘‘Treatment’’ and the intra-subjects factor ‘‘Phase.’’ When their interaction was statistically significant, post hoc analyses were carried out by means of Student’s t-tests for dependent and independent samples. All analyses were performed using the ‘‘Statistica’’ software package, version 5.5 for windows.
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) anxiety
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes _x0002_The State-Trait Anxiety Inventory (STAI) measures both state anxiety (SA) and trait anxiety (TA). [Results will be summarized as one endpoint with the distinction between either being apparent.]
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Clinical
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Physiological
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Other
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What is the study design? Controlled Trial
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Randomized or Non-Randomized? NCT
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What were the diagnostics or methods used to measure the outcome? Subjective
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Optional: Name of Method or short description _x0002_The State-Trait Anxiety Inventory (STAI) is a questionnaire consisting of 20 items referring to self-reported state anxiety (SA) and 20 items referring to trait anxiety (TA).
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Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda
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Tea
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Measured Measured
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Self-report
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Children
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Adolescents
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Adults Adults
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Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) A control group received no treatment vs coffee containing 80.6–86.73mg caffeine. In addition, measurements were taken before and after caffeine exposure.
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) None
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Provide a general description of results (as reported by the authors). State-trait anxiety A summary of the SA results is provided in Table 4. A significant interaction with SA was observed only in the caffeine (C) treatment group [F(1,18) = 7.49; p < 0.05]. The comparisons of dependent samples showed a tendency toward a decrease in the control group [t(9) = 1.99; p = 0.07] and an increase of SA in the C treatment group [t(9) = 2.02; p = 0.07] (see Fig. 4). The comparisons of independent samples showed no significant differences ( ps > 0.05). No significant effects on TA were observed for any of the treatment groups in any of the ANOVAs performed.
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? Caffeine alone had anxiogenic effects, in contrast to the anxiolytic observed by Nehlig with low doses of caffeine, and no effects were observed with alcohol. Our coffee consumers showed a different pattern of SA response when compared with control subjects; after coffee consumption SA increased in the former group and decreased in the latter group. The dose of caffeine employed (80.6–86.73 mg) is within the range of those commonly administered in studies examining the effects of this substance. As expected, all our subjects exhibited similar TA independently of the treatment received. In accordance with this finding, it is reasonable to suppose that differences in SA observed in the treatment groups were due to the experimental treatment in question rather than to stable individual differences of personality.
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What were the sources of funding? This study is supported by a grant GV2007-083 from ‘‘Generalitat Valenciana,’’ Spain (PI: C.V.-C.).
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What conflicts of interest were reported? All authors declare that they have no conflicts of interest.
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Does the exposure (dose) need to be standardized to the SR? No
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest).
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  Anxiety - LOAEL = 80.6–86.73 mg caffeine
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. single dose only Note this applies to state anxiety only. No significant effect was seen on trait anxiety scores.
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What is the importance of the study with respect to the adverseness of the outcome? Important
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