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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
  Purpose

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 Intervention
Smoking Cessation
Tobacco Dependence
Other: De-nicotinised cigarettes + standard treatment
Other: Standard Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 200
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or over
  • Seeking treatment to stop smoking

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Acute psychiatric illness
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250301

Locations
United Kingdom
Tobacco Dependence Research Unit
London, United Kingdom, E1 2JH
Sponsors and Collaborators
Queen Mary University of London
Pfizer
Investigators
Principal Investigator: Hayden McRobbie Queen Mary University of London
  More Information

No publications provided

Responsible Party: Hayden McRobbie, Dr. Hayden McRobbie, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01250301     History of Changes
Other Study ID Numbers: qmul200910
Study First Received: November 29, 2010
Last Updated: July 16, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Mary University of London:
Smoking Cessation
Tobacco Dependence
De-nicotinised cigarettes

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 25, 2014