Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe

NCT02878421 | Completed

• 1 other identifier: 2014CV10
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms. Participants who wish to quit smoking will be randomized to

1. 1.Switch to electronic cigarettes containing nicotine plus flavor
2. 2.Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Flow mediated Dilation (FMD) between the TC group and the EC-nicotine and EC-nicotine free groups

  Baseline and 1 month

Secondary Outcomes (8)

• Change in FMD between EC-nicotine and EC-nicotine free groups

  Baseline and 1 month

• Change in FMD between TC and EC groups combined

  Baseline and 1 month

• Change in oxidised LDL between the TC, EC-nicotine free and EC-nicotine groups

  Baseline and 1 month

• Change in PAI-1 between the TC, EC-nicotine free and EC-nicotine groups

  Baseline and 1 month

• Change in hs-CRP between the TC, EC-nicotine free and EC-nicotine groups

  Baseline and 1 month

Study Arms (3)

tobacco cigarette

ACTIVE COMPARATOR

Intervention: tobacco cigarettes min 15/day

Other: Tobacco cigarette

e.cigarettes + 16mg nicotine & flavor

ACTIVE COMPARATOR

Intervention: One flavoured electronic cigarette 16mg nicotine/day

Device: electronic cigarette + 16mg nicotine & flavor

e.cigarettes + 0mg nicotine & flavour

ACTIVE COMPARATOR

Intervention: One electronic cigarette with flavour +0mg nicotine/day

Other: electronic cigarette + 0mg nicotine & flavor

Interventions

electronic cigarette + 16mg nicotine & flavor DEVICE

comparison of different strengths of nicotine

Also known as: vapourlites, e.cigarette

e.cigarettes + 16mg nicotine & flavor

electronic cigarette + 0mg nicotine & flavor OTHER

comparison of different strengths of nicotine

Also known as: vapourlites, e.cigarette

e.cigarettes + 0mg nicotine & flavour

Tobacco cigarette OTHER

Participant to remain on traditional cigarettes for 28 days

Also known as: Traditional cigarette, any brand

tobacco cigarette

Eligibility Criteria

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

You may qualify if:

• Aged 18 years and over
• Currently smoking ≥15 full strength tobacco cigarettes per day for at least 2 years, or roll-up tobacco equivalent (cigar or pipe smokers not included).
• Willing to stop tobacco cigarettes for period of study if required
• Willing not to use electronic cigarettes if required
• Able to give informed consent

You may not qualify if:

• Pregnant or lactating.
• Women of childbearing potential who do not abstain from sex or use effective contraception.
• On current prescribed medication for cardiovascular disease.
• History of cardiovascular disease (excluding hypertension), diabetes, active malignance or chronic renal disease.
• Nut allergy
• Participation in another clinical trial (other than observational trials and registries) with an investigational product and/or intervention within 30 days before visit 1.

Sponsors & Collaborators

• University of Dundee: lead
• NHS Tayside: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (1)

• George J, Hussain M, Vadiveloo T, Ireland S, Hopkinson P, Struthers AD, Donnan PT, Khan F, Lang CC. Cardiovascular Effects of Switching From Tobacco Cigarettes to Electronic Cigarettes. J Am Coll Cardiol. 2019 Dec 24;74(25):3112-3120. doi: 10.1016/j.jacc.2019.09.067. Epub 2019 Nov 15.

  PMID: 31740017 DERIVED

MeSH Terms

Conditions

Vascular Diseases

Interventions

Tobacco Use Cessation Devices; Electronic Nicotine Delivery Systems; Nicotine; Flavoring Agents

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jacob George

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: August 18, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

GB (1)