EVAPE: Evaluation of the Addictive Potential of E-Cigarettes

Sponsor

Central Institute of Mental Health, Mannheim (Other)

Overall Status

Recruiting

CT.gov ID

NCT04772014

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine the subject matter from a neurobiological and a neuropsychological vantage point to ascertain whether the e-cigarette is potentially as addictive as the traditional tobacco cigarette.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Use Disorder Tobacco Use Disorder

Detailed Description

This project aims to examine the addictive potential of e-cigarettes through three different lenses, combining neurobiological, sociological and epidemiological research methods and levels of observation. The neurobiological perspective will investigate the rewarding effects of vaping, using neurobiological and neuropsychological measurements on e-cigarette users, as compared to nicotine-naïve participants.

The researchers will use established fMRI paradigms to measure the reward potential of e-cigarettes: First, craving will be investigated in an experimental approach by presenting conditioned stimuli to participants; and second, motivation for e-cigarettes compared to combustible cigarettes or money will be measured in an experimental work task. In addition, a dot-probe-task will be used in combination with eye-tracking to measure the attentional bias for e-cigarette stimuli. As part of the neuropsychological assessment outside the fMRI, the approach bias for smoking cues will also be investigated. The aim is to examine whether chronic use of e-cigarettes leads to similar conditioning processes and comparable aspects of motivation as that of traditional tobacco cigarettes.

The investigators will examine the punishment potential of e-cigarettes in a secondary research question, using questionnaires on withdrawal and on the consequences of smoking, both for traditional tobacco and for e-cigarettes.

The results of this project are relevant for the development of preventive healthcare and new treatment options. The neurobiological approach will also provide implications for individualized therapy by identifying consumer groups with different neuronal patterns.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Addictive Potential of the E-Cigarette: Neurobiological, Sociological and Epidemiological Perspectives

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
e-cigarette users daily e-cigarette use (additional smoking of traditional tobacco cigarettes is not an exclusion criterion)
nicotine-naïve lifetime consumption of less than 20 cigarettes or e-cigarettes

Outcome Measures

Primary Outcome Measures

Cue-reactivity [reward potency] [examination day 1 (single examination, no follow-up)]
fMRI to assess group differences in task-specific brain activation patterns using cue-reactivity task (Vollstädt-Klein et al. 2011)
Motivation [reward potency] [examination day 1 (single examination, no follow-up)]
fMRI to assess group differences in task-specific brain activation patterns using the MOTTA-task (Bühler et al. 2010);
Attentional-bias to smoking cues [reward potency] [examination day 1 (single examination, no follow-up)]
measured with reaction time differences (in milliseconds) using the smoke-related dot-probe task (Vollstadt-Klein et al. 2011) in combination with eye tracking and fMRI to assess group differences in task-specific eye movement and brain activation patterns
Approach-bias [reward potency] [examination day 1 (single examination, no follow-up)]
measured with reaction time differences (in milliseconds) using the smoking-related implicit association task (Wiers et al. 2016). [reaction time differences is not a change over time; it is measured during one experimental session]
Craving (CAS-CS) [reward potency] [examination day 1 (single examination, no follow-up)]
Assessment of self-reported craving for cigarette smoking using Craving Automatized Scale for Cigarette Smoking (CAS-CS): adapted from CAS-A (Vollstädt-Klein et al., 2015). 5 subscales (factors): Factor 1 ("only aware in hindsight") ranges from 0 to 35, factor 2 ("no deliberate decision") from 0 to 35, factor 3 ("contrary to intention") from 0 to 40, factor 4 ("no perception") from 0 to 20, and factor 5 ("no control") from 0 to 10, higher score means more habitual smoking.
Craving (QSU) [reward potency] [examination day 1]
Assessment of self-reported craving for cigarette smoking using Questionnaire of Smoking Urges (QSU, Müller et al. 2001); two subscales: "intention and desire to smoke / anticipation of pleasure from smoking" (range 11 - 77) and "anticipation of relief from negative affect and nicotine withdrawal / urgent and overwhelming desire to smoke" (range 10 - 70) high values represent high craving.
Craving (QSU) [reward potency] [examination day 2 (8-24 hours after examination day 1)]
Assessment of self-reported craving for cigarette smoking using Questionnaire of Smoking Urges (QSU, Müller et al. 2001); two subscales: "intention and desire to smoke / anticipation of pleasure from smoking" (range 11 - 77) and "anticipation of relief from negative affect and nicotine withdrawal / urgent and overwhelming desire to smoke" (range 10 - 70) high values represent high craving.
Craving (CAS-V) [reward potency] [examination day 1 (single examination, no follow-up)]
Assessment of self-reported craving for e-cigarettes using Craving Automatized Scale for Vaping (CAS-V): adapted from CAS-A (Vollstädt-Klein et al., 2015). 5 subscales (factors): Factor 1 ("only aware in hindsight") ranges from 0 to 35, factor 2 ("no deliberate decision") from 0 to 35, factor 3 ("contrary to intention") from 0 to 40, factor 4 ("no perception") from 0 to 20, and factor 5 ("no control") from 0 to 10, higher score means more habitual vaping.
Craving (QVC) [reward potency] [examination day 1]
Assessment of self-reported craving for e-cigarettes using Questionnaire of Vaping Craving (QVC; Dowd et al. 2018) 3 factors: Desire, Intention, Positive Outcome. Vaping craving ratings are made on a 7-point scale (1 = strongly disagree to 7 = strongly agree). high values represent high craving.
Craving (QVC) [reward potency] [examination day 2 (8-24 hours after examination day 1)]
Assessment of self-reported craving for e-cigarettes using Questionnaire of Vaping Craving (QVC; Dowd et al. 2018) 3 factors: Desire, Intention, Positive Outcome. Vaping craving ratings are made on a 7-point scale (1 = strongly disagree to 7 = strongly agree). high values represent high craving.

Secondary Outcome Measures

Withdrawal symptoms [punishment potency] [examination day 1]
Assessment of Withdrawal symptoms of (e-cigarette) smoking using Wisconsin Smoking Withdrawal Scale (Welsch et al., 1999). 7 Subscales: anger, anxiety, concentration, craving, hunger, sadness, sleep. Each emotion is determined by the mean of each item that applies.
Withdrawal symptoms [punishment potency] [examination day 2 (8-24 hours after examination day 1)]
Assessment of Withdrawal symptoms of (e-cigarette) smoking using Wisconsin Smoking Withdrawal Scale (Welsch et al., 1999). 7 Subscales: anger, anxiety, concentration, craving, hunger, sadness, sleep. Each emotion is determined by the mean of each item that applies.
Negative consequences (SCQ) [punishment potency] [examination day 1 (single examination, no follow-up)]
Assessment of negative consequences of cigarette smoking using the Short Smoking Consequences Questionnaire (modified version of the SCQ (Brandon & Baker, 1991). Assesses cigarette smoking outcome expectancies among adolescents and young adults. 21-items, 10-point Likert scale (0=completely unlikely to 9=completely likely) to rate the likelihood of occurrence of each smoking consequence item. The four factors are consistent with the original SCQ subscales and include Negative Consequences (4 items), Positive Reinforcement (5 items), Negative Reinforcement (7 items), and Appetite-Weight Control (5 items). Higher scores stand for higher likelihood of consequences.
Negative consequences (VCQ) [punishment potency] [examination day 1 (single examination, no follow-up)]
Assessment of negative consequences of vaping e-cigarettes using the Short Vaping Consequences Questionnaire (modified version of the SCQ (Brandon & Baker, 1991). Assesses vaping e-cigarette outcome expectancies among adolescents and young adults. 21-items, 10-point Likert scale (0=completely unlikely to 9=completely likely) to rate the likelihood of occurrence of each vaping consequence item. The four factors are consistent with the original SCQ subscales and include Negative Consequences (4 items), Positive Reinforcement (5 items), Negative Reinforcement (7 items), and Appetite-Weight Control (5 items). Higher scores stand for higher likelihood of consequences.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

E-cigarette consumers: daily e-cigarette use (additional smoking of classic tobacco cigarettes is not an exclusion criterion)
Nicotine Naïve: lifetime consumption of less than 20 cigarettes or e-cigarettes.
normal or correctable eyesight
sufficient ability to communicate with investigators and answer questions in both written and verbal format
ability to provide fully informed consent and to use self-rating scales

Exclusion Criteria:

common exclusion criteria for MRI (e.g. metal, claustrophobia, pregnancy)
severe internal, neurological, and/or psychiatric comorbidities
other Axis I mental disorders other than TUD or specific phobias within the last 12 months
psychotropic medication within the last 14 days
positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
positive pregnancy test

The inclusion and exclusion criteria are checked in advance in a telephone screening. Smokers are asked not to smoke for eight hours before the examination.