Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

Not Applicable

Completed

• Conditions: Nicotine Withdrawal
• Interventions: Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette; Behavioral: Stress Ball vs Nicotine-free E-Cigarette

• Registration Number: NCT01414998
• Lead Sponsor: Queen Mary University of London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Study Start: 2012-05
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 18 years or over
• Smokes at least 10 cigarettes per day
• Smokes first cigarette within 1 hour of waking

Exclusion Criteria

• pregnant or breastfeeding
• acute psychiatric illness
• currently enrolled in other research projects
• current use of ECs or Denics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
De-nicotinised Cigarette	Nicotine-free E-Cigarette vs De-nicotinised Cigarette	This will be the experimental arm for study 2
Nicotine-free Electronic Cigarette (1)	Stress Ball vs Nicotine-free E-Cigarette	This will be the experimental arm for study 1
Stress Ball	Stress Ball vs Nicotine-free E-Cigarette	This is the active comparator for study 1
Nicotine-free Electronic Cigarette (2)	Nicotine-free E-Cigarette vs De-nicotinised Cigarette	This will be the active comparator for study 2

Primary Outcome Measures

Name	Time	Method
Urge to smoke at 10 minutes post product use	10 minutes	Urges to smoke will be measured at 10 minutes after use of products

Secondary Outcome Measures

Name	Time	Method
Tobacco withdrawal symptom ratings over 1 hour	1 hour	Change withdrawal ratings one hour after product use
Tobacco withdrawal symptom ratings over one day	1 day	Change in tobacco withdrawal symptom ratings over a day

Trial Locations

Locations (1)

Tobacco Dependence Research Unit; 🇬🇧 London, United Kingdom