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Completed

NCT Number: NCT01250301

De-nicotinised Cigarettes Study

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.

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Key information

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
  • Seeking treatment to stop smoking

Exclusion criteria

  • Pregnant or breastfeeding
  • Acute psychiatric illness

Treatment and study plan

De-nicotinised cigarettes + standard treatment

Other

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

standard treatment

Other

Participants will receive standard treatment from the NHS Stop Smoking Service.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Pfizer

Registry information

Official study title

Complementing Current NHS Stop Smoking Service Treatments for Smokers With Behavioural Replacement: The Role of De-nicotinised Cigarettes

Acronym: Denic

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2010
Registry last updated
Jul 17, 2012

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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