De-nicotinised Cigarettes Study (Denic)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Hayden McRobbie, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01250301
First received: November 29, 2010
Last updated: July 16, 2012
Last verified: July 2012

November 29, 2010
July 16, 2012
July 2011
April 2012   (final data collection date for primary outcome measure)
Urges to smoke in first week of abstinence [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Differences in urges to smoke in the first week of abstinence between participants who receive a behavioural replacement (DNCs) plus standard NHS SSS treatment, with those who receive standard NHS SSS treatment alone, will be measured by the Mood and Physical Symptoms Scale (MPSS; West & Hajek, 2004).
Same as current
Complete list of historical versions of study NCT01250301 on ClinicalTrials.gov Archive Site
  • Change in ratings of tobacco withdrawal symptoms, measured by the MPSS [ Time Frame: First 4 weeks of abstinence (from baseline- 4 weeks post-quit) ] [ Designated as safety issue: No ]
  • CO-validated continuous abstinence rates [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]
    CO-validated continuous abstinence rates will be measured 1-4 weeks following the target quit day in the standard treatment condition and 1-4 weeks following cessation of DNCs in the DNC condition.
  • Acceptability and user reactions to DNCs [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Urges to smoke 24 hours after quitting, measured by the MPSS [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Profile of adverse effects up to 12 weeks post quitting [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Reactions to smoking cues [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The differences in reactions to smoking cues between the 2 groups will be measured with smoking-related images and by the Cue Exposure Subscale of the Wisconsin Inventory for Smoking Dependence (WISDM-68; Piper, et al., 2004).
  • Change in ratings of tobacco withdrawal symptoms, measured by the MPSS [ Time Frame: First 4 weeks of abstinence ] [ Designated as safety issue: No ]
  • CO-validated continuous abstinence rates [ Time Frame: 4 weeks plus 12 week follow-up ] [ Designated as safety issue: No ]
    CO-validated continous abstinence rates will be measured 1-4 weeks following the target quit day in the standard treatment condition and 1-4 weeks following cessation of DNCs in the DNC condition. A follow up measurment at 12 weeks will also be taken.
  • Acceptability and user reactions to DNCs [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Urges to smoke 24 hours after quitting, measured by the MPSS [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Profile of adverse effects up to 12 weeks post quitting [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Reactions to smoking cues [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The differences in reactions to smoking cues between the 2 groups will be measured by the Cue Exposure Subscale of the Wisconsin Inventory for Smoking Dependence (WISDM-68; Piper, et al., 2004).
Not Provided
Not Provided
 
De-nicotinised Cigarettes Study
Complementing Current NHS Stop Smoking Service Treatments for Smokers With Behavioural Replacement: The Role of De-nicotinised Cigarettes

The aim of this study is to determine if using a behavioural replacement for smoking (de-nicotinised cigarettes; DNCs), in addition to standard treatment during the first two weeks after the target quit date, can reduce urges to smoke over the first 4-weeks of abstinence. Two hundred smokers who want to quit will be recruited from the community. They would all receive standard smoking cessation treatment from the NHS Stop Smoking Service (NHS SSS), which uses a combination of stop smoking medication (e.g. nicotine replacement therapy, Champix) and motivational support. On their target quit date, participants would be randomised to receive behavioural replacement ( i.e. use of de-nicotinised cigarettes) plus standard treatment for the first two weeks of their quit attempt, or to continue with standard treatment alone. De-nicotinised cigarettes are similar to standard cigarettes except that they do not deliver nicotine to the smoker. Participants will rate their urges to smoke at each week. Standard NHS SSS measures will also be taken in addition to user acceptability ratings and reactions to smoking cues.

The hypothesis is that complementing current NHS SSS treatments with de-nicotinised cigarettes, to address the non-nicotine factors associated with smoking and to help extinguish smoking behaviour, would result in lower urges to smoke than standard treatment alone.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Smoking Cessation
  • Tobacco Dependence
  • Other: De-nicotinised cigarettes + standard treatment

    Participants will receive de-nicotinised cigarettes to use as required for 2 weeks after their quit day. These cigarettes are intended to provide a replacement for the behavioural and sensory aspects of smoking without supplying nicotine.

    Participants will also receive standard NHS Stop Smoking Service treatment. This is a combination of weekly behavioural support and medication (e.g. nicotine replacement therapy/varenicline).

    Other Names:
    • NHS Stop Smoking Service
    • De-nicotinised cigarettes
  • Other: Standard Treatment
    Participants will receive standard treatment from the NHS Stop Smoking Service.
  • Experimental: De-nicotinised cigarettes + standard treatment
    Intervention: Other: De-nicotinised cigarettes + standard treatment
  • Active Comparator: Standard treatment
    Intervention: Other: Standard Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or over
  • Seeking treatment to stop smoking

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Acute psychiatric illness
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01250301
qmul200910
No
Hayden McRobbie, Queen Mary University of London
Queen Mary University of London
Pfizer
Principal Investigator: Hayden McRobbie Queen Mary University of London
Queen Mary University of London
July 2012

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