Evaluation of the Addictive Potential of E-Cigarettes

NCT04772014 | Completed

• 1 other identifier: EVAPE
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Use Disorder; Tobacco Use Disorder

Keywords

Nicotine; Electronic Nicotine Delivery Systems (ENDS); Addiction; Craving

Outcome Measures

Primary Outcomes (10)

• Cue-reactivity [reward potency]

  fMRI to assess group differences in task-specific brain activation patterns using cue-reactivity task (Vollstädt-Klein et al. 2011)

  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);

  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

  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). \[reaction time differences is not a change over time; it is measured during one experimental session\]

  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.

  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.

  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.

  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.

  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.

  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.

  examination day 2 (8-24 hours after examination day 1)

Secondary Outcomes (4)

• Withdrawal symptoms [punishment potency]

  examination day 1

• Withdrawal symptoms [punishment potency]

  examination day 2 (8-24 hours after examination day 1)

• Negative consequences (SCQ) [punishment potency]

  examination day 1 (single examination, no follow-up)

• Negative consequences (VCQ) [punishment potency]

  examination day 1 (single examination, no follow-up)

Study Arms (2)

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

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

Location

Related Publications (1)

• 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.

  PMID: 34794514 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary cotinine level

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping; Behavior, Addictive

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Compulsive Behavior; Impulsive Behavior

Study Officials

• Sabine Vollstädt-Klein

  ZI Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: February 25, 2021
• Study Start: December 1, 2020
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

DE (1)