Clinical trial NCT04772014: Evaluation of the Addictive Potential of E-Cigarettes
Official title: The Addictive Potential of the E-Cigarette: Neurobiological, Sociological and Epidemiological Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nicotine Use Disorder
Tobacco Use Disorder
Keywords: Nicotine
Electronic Nicotine Delivery Systems (ENDS)
Addiction
Craving
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 81
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group 1: e-cigarette users, recruited from the local community group 2: nicotine-naïve (healthy controls), recruited from the local community

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cue-reactivity [reward potency]
timeFrame: examination day 1 (single examination, no follow-up)
measure: Motivation [reward potency]
timeFrame: examination day 1 (single examination, no follow-up)
measure: Attentional-bias to smoking cues [reward potency]
timeFrame: examination day 1 (single examination, no follow-up)
measure: Approach-bias [reward potency]
timeFrame: examination day 1 (single examination, no follow-up)
measure: Craving (CAS-CS) [reward potency]
timeFrame: examination day 1 (single examination, no follow-up)
measure: Craving (QSU) [reward potency]
timeFrame: examination day 1
measure: Craving (QSU) [reward potency]
timeFrame: examination day 2 (8-24 hours after examination day 1)
measure: Craving (CAS-V) [reward potency]
timeFrame: examination day 1 (single examination, no follow-up)
measure: Craving (QVC) [reward potency]
timeFrame: examination day 1
measure: Craving (QVC) [reward potency]
timeFrame: examination day 2 (8-24 hours after examination day 1)
Secondary outcomes:
measure: Withdrawal symptoms [punishment potency]
timeFrame: examination day 1
measure: Withdrawal symptoms [punishment potency]
timeFrame: examination day 2 (8-24 hours after examination day 1)
measure: Negative consequences (SCQ) [punishment potency]
timeFrame: examination day 1 (single examination, no follow-up)
measure: Negative consequences (VCQ) [punishment potency]
timeFrame: examination day 1 (single examination, no follow-up)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Study officials:
affiliation: ZI Mannheim
name: Sabine Vollstädt-Klein
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vollstadt-Klein S, Grundinger N, Gorig T, Szafran D, Althaus A, Mons U, Schneider S. Study protocol: evaluation of the addictive potential of e-cigarettes (EVAPE): neurobiological, sociological, and epidemiological perspectives. BMC Psychol. 2021 Nov 18;9(1):181. doi: 10.1186/s40359-021-00682-8.