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Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes (SenRep)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dunja Przulj, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01414998
First received: August 10, 2011
Last updated: March 19, 2013
Last verified: March 2013

August 10, 2011
March 19, 2013
May 2012
March 2013   (final data collection date for primary outcome measure)
Urge to smoke at 10 minutes post product use [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Urges to smoke will be measured at 10 minutes after use of products
Urge to smoke at 10 minutes post product use. [ Designated as safety issue: No ]
The primary outcome measure is comparison of cue-induced urges to smoke at 10 minutes post product use, between the nicotine-free EC and stress ball condition in Study 1, and between the Denic and nicotine-free EC in Study 2.
Complete list of historical versions of study NCT01414998 on ClinicalTrials.gov Archive Site
  • Tobacco withdrawal symptom ratings over 1 hour [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Change withdrawal ratings one hour after product use
  • Tobacco withdrawal symptom ratings over one day [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Change in tobacco withdrawal symptom ratings over a day
  • Tobacco withdrawal symptom ratings over 1 hour [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Comparison between the EC and stress ball in Study 1 and EC and Denic in Study 2, on tobacco withdrawal symptom ratings over 1 hour.
  • Tobacco withdrawal symptom ratings over one day [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Comparison between the EC and stress ball in Study 1, and EC and Denic in Study 2, on tobacco withdrawal symptom ratings following a days use.
  • Product ratings and preferences [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Comparison between the EC and stress ball in Study 1, and EC and Denic in Study 2, on product ratings (satisfaction, helpfullness, user acceptability) and preferences following a days use.
  • Interactions between level of behavioural dependence and efficacy of products [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes
The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Nicotine Withdrawal
  • Behavioral: Stress Ball vs Nicotine-free E-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.

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

    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.

  • Active Comparator: Stress Ball
    This is the active comparator for study 1
    Intervention: Behavioral: Stress Ball vs Nicotine-free E-Cigarette
  • Experimental: De-nicotinised Cigarette
    This will be the experimental arm for study 2
    Intervention: Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette
  • Experimental: Nicotine-free Electronic Cigarette (1)
    This will be the experimental arm for study 1
    Intervention: Behavioral: Stress Ball vs Nicotine-free E-Cigarette
  • Active Comparator: Nicotine-free Electronic Cigarette (2)
    This will be the active comparator for study 2
    Intervention: Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01414998
qmul1606
No
Dunja Przulj, Queen Mary University of London
Queen Mary University of London
Not Provided
Principal Investigator: Dunja Przulj Queen Mary University of London
Queen Mary University of London
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP