An interventional study of Stress Ball vs Nicotine-free E-Cigarette and Nicotine-free E-Cigarette vs De-nicotinised Cigarette in Nicotine Withdrawal, sponsored by Queen Mary University of London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-20.
Sponsored by Queen Mary University of London · Not applicable, Interventional, and Treatment
There are currently two sensorimotor replacement products which may be of benefit in smoking cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the purpose of this project is to investigate whether these replacements can help to alleviate tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be separated into two studies, following the same design and procedures.
Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool (e.g. stress ball) which provides no smoking-related cues.
Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement which only delivers some of the conditioned sensorimotor cues (i.e. ECs).
The investigators hypothesise that the EC will be more effective at reducing withdrawal symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the Denic will be more effective than the EC.
Queen Mary University of London is the lead sponsor of 253 studies on the registry; 59 are open to participants now.
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This is the active comparator for study 1
Behavioral: Stress Ball vs Nicotine-free E-Cigarette
This will be the experimental arm for study 2
Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette
This will be the experimental arm for study 1
Behavioral: Stress Ball vs Nicotine-free E-Cigarette
This will be the active comparator for study 2
Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette
In a cross over design, participants will be randomly allocated to: 1. use a stress ball for 5 minutes during a 1 hour controlled experiment. They will also use the stress ball for one day outside of the study centre. 2. use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre. One week later participants will complete the other arm.
In a cross over design, participants will be randomly allocated to: 1. use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre. 2. smoke 1 de-nicotinised cigarette during a 1 hour controlled experiment. They will also be given a pack to smoke ad-libitum for one day outside of the study centre. One week later participants will complete the other arm.
Urge to smoke at 10 minutes post product use
Urges to smoke will be measured at 10 minutes after use of products
Time frame: 10 minutes
Tobacco withdrawal symptom ratings over 1 hour
Change withdrawal ratings one hour after product use
Time frame: 1 hour
Tobacco withdrawal symptom ratings over one day
Change in tobacco withdrawal symptom ratings over a day
Time frame: 1 day
The record gives a start of May 2012, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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