Indiana Univerisity Purdue University Indianapolis
Indianapolis, Indiana, 46202, United States
NCT Number: NCT03449017
The purpose of this study is to 1) examine cognitive acuity following e-cig use (as compared to no e-cig use), 2) examine motor coordination following beer and e-cig use (as compared to beer consumption only).
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
Participants will be recruited via study fliers and notices in the community and via word-of-mouth. After viewing study advertisements, participants will call the lab and complete an over the phone screening questionnaire (approximately 10 minutes) with a trained research assistant (trained by PI, completed CITI training). If qualified participants will schedule two sessions (each approximately 4 hours for each session) to come to the lab and complete the study. Participants will receive an appointment reminder by e-mail approximately 48 hours prior to their scheduled study time. Two sessions will be scheduled (in counterbalanced order): One in which the participant will be exposed to e-cigarette cue and be allowed to use their e-cigarette during the alcohol taste test (e-cig cue session) and one in which they will not be exposed to e-cig cues or be allowed to use their e-cig during the alcohol taste test (no e-cig cue session). Participants will be asked to not schedule any sessions on days or the day before they have obligations (e.g. tests, work) in order to help ensure their participation in the study does not affect outside obligations. Participants will be paid $100 for study completion
After qualifying for the study in the phone screen, participants will complete two separate counterbalanced sessions: the e-cig cue session and the no e-cig cue session.
Three beers with similar per volume alcohol content (Bud Light- 4.2% alcohol, Miller Light-4.2% alcohol, Sam Adams Light-4.1% alcohol) will be provided. In order to limit overall breath alcohol content of participants, Buckler's and O'Doul's (both 0% alcohol) will also be provided. All drinks will be measured (in mL) by a highly trained research assistant over the age of 21, and poured into separate cold glasses. Beers will be placed on a table in front of where the participant will be seated. In session 2, participants will be told researchers have selected their previously rated favorite beer from session 1, along with new beers to rate. Participants will be told to drink as much or as little of each beer as they like and rate each beer on various qualities (e.g., taste, aroma, drinkability), but to at least drink enough to rate each beer. Participants will be instructed that they have approximately 60 minutes to complete the taste test.
After approximately 60 minutes, participants will have their BrAC measured (rinsing with water prior to measurement), will report their alcohol and e-cig craving and mood (craving assessment 5), and beers will be removed and measured (in mL). Participants will complete a field sobriety test which researchers are presenting as the motor coordination portion of the study. The participant's e-cig will be weighed at this time to calculate overall nicotine dose administered during the ad libitum session. Participants will be then be given access to snacks and movies and asked to remain in the room until the end of the session and their BrAC is at or below 0.02 and they show no detectable signs of intoxication on a field sobriety test. Preliminary data suggest that, on average, college students consume approximately half of the beer presented during ad lib drinking sessions. The maximum BrAC expected during the ad libitum session is approximately .05 (driving limit is .08 in the State of Indiana), with the maximum expected time of approximately 2.5 hours to return participants' BrAC to 0.02 or less (see Table 3); therefore, this is the time set across all participants. On average, participants reach a BrAC of zero after approximately 1-1.5 hours. Therefore, the researchers have set 1.25 hours as the time across all participants for the sobering up period; however, if participants BrAC is above .02 at the 1.25 hour mark, they will stay in the lab until they reach a BrAC of .02 or less.
Participants will be allowed to use their e-cig ad libitum during the 60-minute session. Each participant will use as much or as little of the e-cig as they would like. Estimates of nicotine exposure to 18-24% nicotine content e-cigs results in .08mg/ml blood concentration over a one-hour period. Therefore, researchers expect the exposure to be in the range of ¼ - 1/5 of this amount, or, approximately 0.016-0.02 mg/ml blood concentration. Toxic levels are approximately 200 mg/ml.
After this time has passed, participants will have their sobriety verified, and will complete a manipulation check, in which they will be asked what they believed to be the goals of the study, in order to assess for the believability of the beer taste test. Then, as the session is ending, the study technician will make conversation with the participant and will ask about what the participant did the day of the session and what s/he is doing the day after the session. This is to assess the effect of outside obligations on drinking behaviors. Participants who note significant obligations or guess study hypotheses will have their data excluded from analysis. Finally, participants will be compensated and then dismissed.
In order to diminish the possibility that subjects will leave before official release, the following steps will be taken: 1. Subject keys will be taken upon arrival to the session and returned upon dismissal; 2. Subjects who insist on leaving before these conditions are met will not be paid or rescheduled for further testing and their keys will not be returned if their BrAC is above 0.02, 3. Subjects will be kept in a private room that only exits into laboratory space and will be monitored appropriately by staff to avoid early self-dismissal; 4. Should a subject become belligerent or insist upon leaving when not safe, the PI will be notified to assist to ensure subject safety.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Self-administration of e-cig (10 puffs in 5 minutes) prior to lab task, self-administration of e-cig (10 puffs in 5 minutes) prior to ad lib alcohol, and ad lib e-cig use throughout ad lib alcohol paradigm.
Time frame: Through 15 minute eye-tracking session
-Subtracting average time to respond to alcohol stimuli from the average time to respond to non-alcohol stimuli -Faster reaction times to probes that replace alcohol-related versus control pictures are indicative of alcohol-related attentional biases
Time frame: Through 15 minute eye-tracking session
-Percentage calculated based on the number of trials when gaze was initially directed at the alcohol-related picture and the total number of trials in which a fixation was made on either the alcohol-related or control picture
Time frame: Through 15 minute eye-tracking session
Summing the total amount of time that fixations were directed at the regions of the screen occupied by the alcohol pictures and control pictures, respectively
Time frame: 60 minutes ad libitum alcohol session
mL of beer consumed
Time frame: 60 minutes ad libitum alcohol session
Number of times participant takes a hit (inhales and exhales vapor) from their e-cig.
Time frame: 60 minute ad libitum alcohol session
Number of times participant takes a drink of a beer
Time frame: Immediately prior to first e-cig prime, immediately following first e-cig prime , immediately prior to second e-cig prime, immediately following second e-cig prime, immediately following 60 minute ad lib session
0 (not at all) to 10 (very much)
Time frame: Immediately prior to first e-cig prime, immediately following first e-cig prime , immediately prior to second e-cig prime, immediately following second e-cig prime, immediately following 60 minute ad lib session
0 (not at all) to 10 (very much)
Time frame: 30 days prior to study session
Number of days that participant reports using their e-cig during a period of alcohol consumption
Time frame: Pre and post 60 minute ad libitum alcohol session
The weight (grams) of the e-cig prior to the ad libitum alcohol session minus the weight (grams) of the e-cig following the ad libitum alcohol session
Indiana University
Other
The Effects of Electronic Cigarette Use on Alcohol Consumption: A Neurocognitive and Behavioral Investigation
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