Nicotine Use DisorderEVAPENCT04772014
Evaluation of the Addictive Potential of E-Cigarettes
An observational study of Nicotine Use Disorder and Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Use Disorder, Tobacco Use Disorder
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2020to 29 Aug 2023
- Phase
- Observational
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: group 1: e-cigarette users, recruited from the local community group 2: nicotine-naïve (healthy controls), recruited from the local community
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim
About this study
Official title: The Addictive Potential of the E-Cigarette: Neurobiological, Sociological and Epidemiological Perspectives
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.
Read the 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.
- Conditions
- Nicotine Use Disorder, Tobacco Use Disorder
- Keywords
- Nicotine, Electronic Nicotine Delivery Systems (ENDS), Addiction, Craving
- Medical subject headings
- Tobacco Use Disorder, Vaping, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue-reactivity [reward potency]
fMRI to assess group differences in task-specific brain activation patterns using cue-reactivity task (Vollstädt-Klein et al. 2011)
Measured: examination day 1 (single examination, no follow-up)
Motivation [reward potency]
fMRI to assess group differences in task-specific brain activation patterns using the MOTTA-task (Bühler et al. 2010);
Measured: examination day 1 (single examination, no follow-up)
Attentional-bias to smoking cues [reward potency]
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
Measured: examination day 1 (single examination, no follow-up)
Approach-bias [reward potency]
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]
Measured: examination day 1 (single examination, no follow-up)
Craving (CAS-CS) [reward potency]
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.
Measured: examination day 1 (single examination, no follow-up)
Craving (QSU) [reward potency]
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.
Measured: examination day 1
Craving (QSU) [reward potency]
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.
Measured: examination day 2 (8-24 hours after examination day 1)
Craving (CAS-V) [reward potency]
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.
Measured: examination day 1 (single examination, no follow-up)
Craving (QVC) [reward potency]
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.
Measured: examination day 1
Craving (QVC) [reward potency]
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.
Measured: examination day 2 (8-24 hours after examination day 1)
Secondary outcomes (4)
Withdrawal symptoms [punishment potency]
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.
Measured: examination day 1
Withdrawal symptoms [punishment potency]
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.
Measured: examination day 2 (8-24 hours after examination day 1)
Negative consequences (SCQ) [punishment potency]
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.
Measured: examination day 1 (single examination, no follow-up)
Negative consequences (VCQ) [punishment potency]
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.
Measured: examination day 1 (single examination, no follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Dec 2020
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Vollstädt-Klein, Principal investigator, ZI Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772014
- Sponsor's protocol ID
- EVAPE
- Acronym
- EVAPE
- Status last verified
- Mar 2024
- First submitted
- 30 Dec 2020
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34794514
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addictive Potential of the E-Cigarette: Neurobiological, Sociological and Epidemiological Perspectives
- ClinicalTrials.gov ID
- NCT04772014
- Acronym / sponsor ID
- EVAPE / EVAPE
- Conditions
- Nicotine Use Disorder, Tobacco Use Disorder
- Keywords
- Nicotine, Electronic Nicotine Delivery Systems (ENDS), Addiction, Craving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- group 1: e-cigarette users, recruited from the local community group 2: nicotine-naïve (healthy controls), recruited from the local community
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cue-reactivity [reward potency]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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.
4 secondary outcomes
Withdrawal symptoms [punishment potency]
Time frame: examination day 1
Withdrawal symptoms [punishment potency]
Time frame: examination day 2 (8-24 hours after examination day 1)
Negative consequences (SCQ) [punishment potency]
Time frame: examination day 1 (single examination, no follow-up)
Negative consequences (VCQ) [punishment potency]
Time frame: examination day 1 (single examination, no follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 34794514Vollstadt-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Vollstädt-Klein principal investigator
ZI Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Use Disorder and Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 5 inclusion and 7 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 Mar 2024. 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 Germany. 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?
Cue-reactivity [reward potency] (time frame: examination day 1 (single examination, no follow-up)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772014, which also lists 1 linked publication.
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 Mar 2024.