This trial is active, not recruiting.

Condition healthy volunteers
Treatments e-vapour product, conventional cigarette
Sponsor Imperial Tobacco Group PLC
Start date December 2013
End date November 2016
Trial size 420 participants
Trial identifier NCT02029196, ITG EVP G1 S2


Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems. These may look like conventional cigarettes but do not contain tobacco.

The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.

This trial is to evaluate the safety and tolerability of an e-vapour product.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
e-vapour product
(Active Comparator)
Subjects who continue smoking their usual conventional cigarette (CC) brand.
conventional cigarette

Primary Outcomes

Vital signs
time frame: Up to 12 weeks
time frame: Up to 12 weeks
Lung Function Testing
time frame: Up to 12 weeks
Clinical laboratory parameters
time frame: Up to 12 weeks

Secondary Outcomes

Craving and withdrawal symptoms
time frame: Up to 12 weeks
time frame: Up to 12 weeks
High-density lipoprotein cholesterol
time frame: Up to 12 weeks

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

Inclusion Criteria: - BMI of 18-35kg/m2 - Subjects must be established smokers - Subjects must have smoked five to 30 cigarettes per day for at least one year Exclusion Criteria: - Subjects who have used nicotine replacement therapy within 14 days of the screening - Subjects who have donated blood within 12 months preceding study - Subjects with relevant illness history - Subjects positive for hepatitis or HIV - Subjects with history of drug or alcohol abuse - Subjects with lung function test or vital signs considered unsuitable - Subjects who are trying to stop smoking - Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.

Additional Information

Official title A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product
Principal investigator Jim Bush, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Imperial Tobacco Group PLC.