The Effects of Electronic Cigarette Use on Alcohol Consumption: A Neurocognitive and Behavioral Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- E-cigarette puffs
研究概览
简要总结
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).
详细描述
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.
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Participants will report to the lab where they will undergo informed consent process. Then, the researcher will ask the person to rinse their mouth with water and then will administer a breath alcohol test using a Breathalyzer, by asking the participant to breathe into the breathalyzer for approximately 10 seconds. The breathalyzer produces an immediate reading of BrAC. If > 0.00, a second rinse and reading will be conducted to avoid false positive readings. If positive on the second reading, participants will be excluded from the study, but the participant will not be able to leave the lab until their BrAC falls below 0.02. Participants will then be escorted to a private bathroom and will be asked to give a urine sample in a small cup. The research assistant will then use drug and pregnancy (women only) "dip stick" tests to determine pregnancy or drug use. Results are given within 2 minutes. If positive on either, a second test will be conducted on the same urine sample to avoid false positive readings. If positive again, Dr. Melissa Cyders, HSPP, who will be on call for the study, will be contacted. Dr. Cyders will use her expertise in clinical psychology and she and the research assistant will inform the participant of the positive test and provide the individual with any resources they would like (e.g. obstetrician referrals, physical examination appointment setting, drug use referrals). In case of two positive screens for pregnancy or for any drug other than marijuana, participants will be dismissed from the study. Informed consent and initial screening process takes approximately 15 minutes.
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Participants will fill out the following surveys on a computer about their substance use and other psychological factors: The UPPS-P Impulsive Behavior Scale, the Alcohol Use Disorder Identification Test, the Nicotine and Other Substance Interaction Expectancies Questionnaire E-cig Revised, The Alcohol Expectancy Questionnaire, the Smoking Consequences Questionnaire, the Timeline Follow Back, the Fagerstrom test for Nicotine Dependence, Demographics, current e-cig craving, current alcohol craving, current mood assessment and Smoking Assessments. (approx 25 45 min)
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Participants will complete either the e-cig cue session below or the no-e-cig cue session below (one in session 1 and the other in session 2):
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In the e-cig cue session, participants will be asked to bring their own e-cig and an e-cig refill liquid or cartridge. Researchers are telling participants that the study is examining the effect of nicotine use on cognitive acuity. Participants will then be asked to take 10 puffs from their e-cig over a five-minute period, consistent with findings on average puffs per use.Then, participants will report e-cig and alcohol craving and mood. Following this rating, all participants will then complete the visual dot probe task with eye tracking, using an Eye-Trac D6 Desktop mounted camera. Participants will face a computer, approximately 24 inches from the computer screen, and their eye movements will be calibrated to ensure accuracy of eye movement tracking. For the dot probe task, participants will first see a pair of alcohol-related pictures and matched control pictures, (approximately 7 x 5 inches as used in previous work) which will be presented for 1000ms. After picture offset, a visual probe appears where one of the pictures had previously been presented and participants will be instructed to identify the location of the probe as quickly as possible by pressing either the left or right mouse button. Following completion of the dot-probe tasks, participants will self-report alcohol and e-cig craving and mood (craving assessment 3) and rate the e-cig using the e-cig rating form. (eye-tracking task, including time to calibrate participants eye, takes approximately 30 minutes) Then, participants will be moved into an adjoining research room to complete what researchers are presenting as the motor coordination task. This room is equipped with a comfortable recliner, TV, and computer. Participants will be permitted to use their e-cig throughout the session and will sample 5 beers (two are non-alcoholic). Participants will be asked to self-report e-cig and alcohol craving and mood (craving assessment 4) and will then be asked to complete a beer taste test (15 minutes for technician to set up beer taste testing). The researcher will ask participants to continue to use their e-cig as they would like throughout the taste test portion of the study. Participants will be given 5 minutes prior to the beginning of the taste test to take 10 puffs of their e-cig. Prior to beginning the taste test, participants will be reminded that they will be dismissed from the study as scheduled and will have to stay for the entire allotted study time, regardless of the amount of beer they consume during the session. They will be given their beer-rating sheet and the researcher will leave the room. Participants will be unaware that the researcher, trained in session coding, will record the timing of e-cig puffs and sips of beer temporally, through the use of the lab's one-way mirror.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, 21 years of age or older
- •Regular alcohol use (reports at least one drink weekly - acceptability of average alcohol consumption will be made on a case by case basis by the PI)
- •No current/prior severe alcohol or substance use disorder (endorsement of > 6 Alcohol/Drug Use history items on the phone screen)
- •Current e-cigarette use (reports at least weekly use - acceptability of average e-cig use will be made on a case by case basis by the PI)
- •Able to understand questionnaires/procedures in English
- •Reports drinking beer (Yes/No on phone screen)
排除标准
- •Pregnant/breast-feeding women (assessed via phone screen and urine screen)
- •Unstable or significant medical disorders that may influence study outcome or participant safety as determined by Melissa Cyders (e.g., liver condition)
- •Current/prior severe alcohol use disorder, current/prior severe substance use disorder (endorsement of > 6 Alcohol/Drug Use history items on the phone screen)
- •Positive urine drug screen for amphetamines/meth-amphetamines, barbiturates, benzodiazapines, cocaine, opiates, or PCP [1-phenylcyclohexyl]
- •Current mental health problems, such as depression, anxiety, post-traumatic stress disorder, bipolar disorder, or schizophrenia (self-reported at phone screen)
- •Positive BrAC reading at the start of any study visit
- •Court-mandated order to not drink alcohol
- •Any condition that, in the judgment of the PI, could place the participant at risk or affect data validity
研究组 & 干预措施
E-cig use condition
Participants self-administer their own electronic cigarette device
干预措施: E-cig use (Behavioral)
结局指标
主要结局
E-cigarette puffs
时间窗: 60 minutes ad libitum alcohol session
Number of times participant takes a hit (inhales and exhales vapor) from their e-cig.
Alcohol sips
时间窗: 60 minute ad libitum alcohol session
Number of times participant takes a drink of a beer
Alcohol related attentional bias-Reaction time
时间窗: 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
Alcohol related attentional bias-Initial orientation
时间窗: 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
Alcohol related attentional bias-Delayed disengagement
时间窗: 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
Amount of beer consumed
时间窗: 60 minutes ad libitum alcohol session
mL of beer consumed
次要结局
- Amount of e-cig used(Pre and post 60 minute ad libitum alcohol session)
- Alcohol craving(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)
- E-cig craving(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)
- Timeline Followback combined e-cig and alcohol use(30 days prior to study session)
研究者
Alexandra Hershberger
PI
Indiana University
