De-nicotinised Cigarettes Study

Smoking Cessation Clinical Trial

— Denic  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250301
• Other study ID #: qmul200910
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: July 16, 2012
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or over

• Seeking treatment to stop smoking

Exclusion Criteria:

• Pregnant or breastfeeding

• Acute psychiatric illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

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).
• Standard Treatment
Participants will receive standard treatment from the NHS Stop Smoking Service.

Locations

Country	Name	City	State
United Kingdom	Tobacco Dependence Research Unit	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in ratings of tobacco withdrawal symptoms, measured by the MPSS		First 4 weeks of abstinence (from baseline- 4 weeks post-quit)	No
Secondary	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	No
Secondary	Acceptability and user reactions to DNCs		2 weeks	No
Secondary	Urges to smoke 24 hours after quitting, measured by the MPSS		24 hours	No
Secondary	Profile of adverse effects up to 12 weeks post quitting		12 weeks	Yes
Secondary	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	No