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Evaluation of the Addictive Potential of E-Cigarettes (EVAPE)

C

Central Institute of Mental Health, Mannheim

Status

Completed

Conditions

Tobacco Use Disorder
Nicotine Use Disorder

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 patients

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

81 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Sabine Vollstädt-Klein

Data sourced from clinicaltrials.gov

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