Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

De-nicotinised Cigarettes Study (Denic)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01250301
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):
Hayden McRobbie, Queen Mary University of London

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Tobacco Dependence Other: De-nicotinised cigarettes + standard treatment Other: Standard Treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complementing Current NHS Stop Smoking Service Treatments for Smokers With Behavioural Replacement: The Role of De-nicotinised Cigarettes
Study Start Date : July 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: De-nicotinised cigarettes + standard treatment 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

Active Comparator: Standard treatment Other: Standard Treatment
Participants will receive standard treatment from the NHS Stop Smoking Service.

Primary Outcome Measures :
  1. Urges to smoke in first week of abstinence [ Time Frame: 1 week ]
    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).

Secondary Outcome Measures :
  1. Change in ratings of tobacco withdrawal symptoms, measured by the MPSS [ Time Frame: First 4 weeks of abstinence (from baseline- 4 weeks post-quit) ]
  2. CO-validated continuous abstinence rates [ Time Frame: 4-weeks ]
    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.

  3. Acceptability and user reactions to DNCs [ Time Frame: 2 weeks ]
  4. Urges to smoke 24 hours after quitting, measured by the MPSS [ Time Frame: 24 hours ]
  5. Profile of adverse effects up to 12 weeks post quitting [ Time Frame: 12 weeks ]
  6. Reactions to smoking cues [ Time Frame: 12 weeks ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 years or over
  • Seeking treatment to stop smoking

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Acute psychiatric illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01250301

Layout table for location information
United Kingdom
Tobacco Dependence Research Unit
London, United Kingdom, E1 2JH
Sponsors and Collaborators
Queen Mary University of London
Layout table for investigator information
Principal Investigator: Hayden McRobbie Queen Mary University of London
Layout table for additonal information
Responsible Party: Hayden McRobbie, Dr. Hayden McRobbie, Queen Mary University of London Identifier: NCT01250301    
Other Study ID Numbers: qmul200910
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by Hayden McRobbie, Queen Mary University of London:
Smoking Cessation
Tobacco Dependence
De-nicotinised cigarettes
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders