Monitoring the Transition From Smoking to E-cigarettes

NCT02752022 | Unknown

• 1 other identifier: 16.0070
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Electronic cigarettes (e-cigarettes) have proved very popular and a meteoric rise in their usage is currently under way. People purchase them as an aid to giving up smoking, to reduce cigarette consumption, to minimise withdrawal symptoms in occupational environments that ban smoking, and in order to continue smoking with decreased health risks. Although the safety and impact on health of electronic cigarettes, especially after long-term use, has not been evaluated, they are generally considered to be far safer alternatives to cigarette smoke. Electronic cigarettes do not generate polycyclic aromatic hydrocarbons, a potent class of carcinogenic chemicals generated during the combustion of tobacco and making important contribution to the cigarette-induced cancer. However, carcinogenic tobacco-specific nitrosamines have been encountered in e-cigarettes being detected in some nicotine cartridges as contaminants, albeit at very low concentrations in comparison with tobacco smoke. Consequently, it is imperative to ascertain the toxicity risk (if any) of consuming nicotine intake through electronic cigarettes. This European Commission funded study will monitor levels of carcinogenic tobacco-specific nitrosamines in urine of heavy smokers who give up smoking and completely transition to e-cigarette use for a period of 4 weeks. Levels of other compounds which are known to be associated with smoking toxicity, such as DNA adducts and DNA methylation, will also be monitored in biological fluids of these subjects. Finally, cigarette craving, mood, anxiety, social anxiety, well-being status and stress hormones will be measured in smokers transitioning to e-cigarettes for 4 weeks to assess the psychological effect of the transition. The results from the study will provide important information on the safety and effectiveness of e-cigarettes for smoking cessation which investigators anticipate to drive policy.

Conditions

Smoking

Keywords

e-cigarettes; nitrosamines; smoking cessation

Outcome Measures

Primary Outcomes (4)

• Change of levels of DNA adducts analysed by high resolution liquid chromatography

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

• Change of levels of tobacco specific nitrosamines analysed by high resolution liquid chromatography

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

• Change of levels of stress hormones analysed by ELISA

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

• Change of levels of DNA methylation analysed by high pressure liquid chromatography-UV

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

Secondary Outcomes (9)

• Change of measures of withdrawal symptoms severity measured by the Fagerstrom test

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

• Change of measures of craving analysed by Minnesota Nicotine Withdrawal Scale

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

• Change of measures of mood analysed by Mood and Physical Symptoms Scale (MPSS)

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

• Change of measures of anxiety analysed by State-Trait Anxiety Inventory

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

• Change of measures of social anxiety analysed by Liebovitz Social Anxiety Test

  Screening, baseline and 3, 7, 21 and 28 days following transition to e-cigarettes

Study Arms (1)

Heavy smokers

Heavy smokers (continuous smoking of \>10 cigarettes per day) for at least 6 months who will give up smoking and switch to nicotine containing e-cigarettes for 28 days to help them quit smoking.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heavy smokers (continuous smoking of \>10 cigarettes per day) for at least 6 months who are willing to give up smoking and switch to nicotine containing e-cigarettes to help them quit smoking

You may qualify if:

• Heavy smokers (continuous smoking of \>10 cigarettes per day) for at least 6 months who are willing to give up smoking and switch to nicotine containing e-cigarettes to help them quit smoking.
• Males and females aged 18-65 years
• Subjects must be willing and able to give informed consent
• Subjects must have understanding of English sufficient that they are able to read and understand the participant information sheet and the informed consent form
• Subjects in the opinion of the Investigator are healthy on the basis of medical history questionnaire and vital signs
• Subjects who will purchase their e-cigarettes kits, e-liquid and/or cartridges from a pharmacy, leading super market, established newsagent chain)

You may not qualify if:

• Severe psychosis, Bipolar Affective Disorder I, prostate cancer, Cushing's syndrome, severe depression with suicidal ideation and intention, brain trauma or other severe neurological disorders (e.g. pan-hypopituitarism) or taking antidepressants, anxiolytics antipsychotics
• Pregnant females and lactating mothers
• History of substance abuse and alcoholism
• History of cardiovascular disease (heart disease, angina, heart attacks, high blood pressure, heart surgery) in the last 6 months.
• Self-declared smokers with low or non-detectable CO readings in their breath when tested with the oxymeter will be excluded from further being studied
• Smokers who are undergoing alternative Nicotine Replacement Therapy (NRT)/pharmacological treatment for smoking cessation (i.e. nicotine patches, nicotine gum, Champix, bupropion)
• Any other condition that in the judgement of the investigator would preclude participation
• Smokers who are unwilling to refrain from smoking for 4 weeks

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, blood, bucal swab, urine

MeSH Terms

Conditions

Smoking; Vaping; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Alexis Bailey

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 26, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)