Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

NCT01414998 | Completed

• 1 other identifier: qmul1606
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Withdrawal

Outcome Measures

Primary Outcomes (1)

• Urge to smoke at 10 minutes post product use

  Urges to smoke will be measured at 10 minutes after use of products

  10 minutes

Secondary Outcomes (2)

• Tobacco withdrawal symptom ratings over 1 hour

  1 hour

• Tobacco withdrawal symptom ratings over one day

  1 day

Study Arms (4)

Stress Ball

ACTIVE COMPARATOR

This is the active comparator for study 1

Behavioral: Stress Ball vs Nicotine-free E-Cigarette

De-nicotinised Cigarette

EXPERIMENTAL

This will be the experimental arm for study 2

Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette

Nicotine-free Electronic Cigarette (1)

EXPERIMENTAL

This will be the experimental arm for study 1

Behavioral: Stress Ball vs Nicotine-free E-Cigarette

Nicotine-free Electronic Cigarette (2)

ACTIVE COMPARATOR

This will be the active comparator for study 2

Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette

Interventions

Stress Ball vs Nicotine-free E-Cigarette BEHAVIORAL

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.

Nicotine-free Electronic Cigarette (1); Stress Ball

Nicotine-free E-Cigarette vs De-nicotinised Cigarette BEHAVIORAL

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.

De-nicotinised Cigarette; Nicotine-free Electronic Cigarette (2)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Tobacco Dependence Research Unit

London, E1 2JH, United Kingdom

Location

Study Officials

• Dunja Przulj

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 11, 2011
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

GB (1)