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Alcohol AbuseNCT03449017

Reactions to E-cigs and Alcohol

A study testing E-cig use in people with Alcohol Abuse and Nicotine Dependence Tobacco Product, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
E-cig use
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
24 Mar 2017to 11 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana Univerisity Purdue University Indianapolis

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: The Effects of Electronic Cigarette Use on Alcohol Consumption: A Neurocognitive and Behavioral Investigation

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).

Read the detailed description

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.

  1. 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.
  2. 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)
  3. 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):
  4. 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. 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.
  5. In the no e-cig cue condition participants will sit for five minutes with a pencil in their hand (similar to an e-cig in size and weight). All participants will report e-cig and alcohol craving and mood (craving assessment 2) and complete the dot probe task and the beer taste test, as described above in the e-cig cue condition, except that no e-cig will be used throughout any portion of the study.
  6. In session 2, participants will complete: breathalyzer, urine drug and pregnancy screen, and either the e-cig cue condition or no e-cig cue condition, as described above.
  7. At the end of session 2, participants will be debriefed. Research Assistants will be thoroughly trained in handling any concerns participants may have following the test, and participants will be given study information, including contact information for the study sponsor, department, and university, as well as counseling services, if appropriate.

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.

Being tested
E-cig use
Keywords
nicotine, alcohol, vape, electronic cigarette
Medical subject headings
Alcoholism, Tobacco Use Disorder, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E-cig useBehavioural

    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.

Study groups in NCT03449017
Study groupRoleWhat they receive
E-cig use conditionExperimentalParticipants self-administer their own electronic cigarette device
Receives: Behavioral: E-cig use

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol related attentional bias-Reaction time

    -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

    Measured: Through 15 minute eye-tracking session

  2. Alcohol related attentional bias-Initial orientation

    -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

    Measured: Through 15 minute eye-tracking session

  3. Alcohol related attentional bias-Delayed disengagement

    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

    Measured: Through 15 minute eye-tracking session

  4. Amount of beer consumed

    mL of beer consumed

    Measured: 60 minutes ad libitum alcohol session

  5. E-cigarette puffs

    Number of times participant takes a hit (inhales and exhales vapor) from their e-cig.

    Measured: 60 minutes ad libitum alcohol session

  6. Alcohol sips

    Number of times participant takes a drink of a beer

    Measured: 60 minute ad libitum alcohol session

Secondary outcomes (4)
  1. Alcohol craving

    0 (not at all) to 10 (very much)

    Measured: 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

  2. E-cig craving

    0 (not at all) to 10 (very much)

    Measured: 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

  3. Timeline Followback combined e-cig and alcohol use

    Number of days that participant reports using their e-cig during a period of alcohol consumption

    Measured: 30 days prior to study session

  4. Amount of e-cig used

    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

    Measured: Pre and post 60 minute ad libitum alcohol session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start24 Mar 2017
  3. Primary completion11 Nov 2018
  4. Study completion11 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
2 session x 2 condition within participant
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03449017
Sponsor's protocol ID
1511771735
Other IDs
F31AA024682
Status last verified
Nov 2018
First submitted
21 Feb 2018
Last updated
29 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing E-cig use in people with Alcohol Abuse and Nicotine Dependence Tobacco Product, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol related attentional bias-Reaction time (time frame: Through 15 minute eye-tracking session). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.

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