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Completed

NCT Number: NCT01414998

Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

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.

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Key information

Conditions

Nicotine Withdrawal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tobacco Dependence Research Unit

London, E1 2JH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Ball vs Nicotine-free E-Cigarette

Behavioral

In a cross over design, participants will be randomly allocated to:

  • 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.
  • 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 E-Cigarette vs De-nicotinised Cigarette

Behavioral

In a cross over design, participants will be randomly allocated to:

  • 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.
  • 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.

Primary outcomes

  1. Urge to smoke at 10 minutes post product use

    Time frame: 10 minutes

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

Secondary outcomes

  1. Tobacco withdrawal symptom ratings over 1 hour

    Time frame: 1 hour

    Change withdrawal ratings one hour after product use

  2. Tobacco withdrawal symptom ratings over one day

    Time frame: 1 day

    Change in tobacco withdrawal symptom ratings over a day

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes

Acronym: SenRep

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 11, 2011
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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