Reactions to E-cigs and Alcohol

NCT03449017 | Completed DMC

• 2 other identifiers: 1511771735F31AA024682
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alcohol Abuse; Nicotine Dependence Tobacco Product

Keywords

nicotine; alcohol; vape; electronic cigarette

Outcome Measures

Primary Outcomes (6)

• 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

  Through 15 minute eye-tracking session

• 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

  Through 15 minute eye-tracking session

• 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

  Through 15 minute eye-tracking session

• Amount of beer consumed

  mL of beer consumed

  60 minutes ad libitum alcohol session

• E-cigarette puffs

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

  60 minutes ad libitum alcohol session

• Alcohol sips

  Number of times participant takes a drink of a beer

  60 minute ad libitum alcohol session

Secondary Outcomes (4)

• 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

• Amount of e-cig used

  Pre and post 60 minute ad libitum alcohol session

Study Arms (1)

E-cig use condition

EXPERIMENTAL

Participants self-administer their own electronic cigarette device

Behavioral: E-cig use

Interventions

E-cig use BEHAVIORAL

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.

E-cig use condition

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Indiana Univerisity Purdue University Indianapolis

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Alcoholism; Tobacco Use Disorder; Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Alexandra R Hershberger

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: 2 session x 2 condition within participant

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 28, 2018
• Study Start: March 24, 2017
• Primary Completion: November 11, 2018
• Study Completion: November 11, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)