De-nicotinised Cigarettes Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking Cessation, Tobacco Dependence

Intervention / Treatment
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* Other: De-nicotinised cigarettes + standard treatment
* Other: Standard Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or over Seeking treatment to stop smoking Exclusion Criteria: Pregnant or breastfeeding Acute psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: De-nicotinised cigarettes + standard treatment<br> | Other: De-nicotinised cigarettes + standard treatment<br>* 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).<br>* Other names: De-nicotinised cigarettes;|
| Active Comparator: Standard treatment<br> | Other: Standard Treatment<br>* Participants will receive standard treatment from the NHS Stop Smoking Service.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urges to smoke in first week of abstinence | 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). | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ratings of tobacco withdrawal symptoms, measured by the MPSS |  | First 4 weeks of abstinence (from baseline- 4 weeks post-quit) | 
| CO-validated continuous abstinence rates | 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. | 4-weeks | 
| Acceptability and user reactions to DNCs |  | 2 weeks | 
| Urges to smoke 24 hours after quitting, measured by the MPSS |  | 24 hours | 
| Profile of adverse effects up to 12 weeks post quitting |  | 12 weeks | 
| Reactions to smoking cues | 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). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Tobacco Dependence, De-nicotinised cigarettes