De-nicotinised Cigarettes Study

Not Applicable

Completed

• Conditions: Smoking Cessation; Tobacco Dependence
• Interventions: Other: De-nicotinised cigarettes + standard treatment; Other: Standard Treatment

• Registration Number: NCT01250301
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Study Start: 2011-07
• Primary Completion: 2012-04
• Status Verified: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 18 years or over
• Seeking treatment to stop smoking

Exclusion Criteria

• Pregnant or breastfeeding
• Acute psychiatric illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
De-nicotinised cigarettes + standard treatment	De-nicotinised cigarettes + standard treatment	-
Standard treatment	Standard Treatment	-

Primary Outcome Measures

Name	Time	Method
Urges to smoke in first week of abstinence	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

Name	Time	Method
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	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.
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	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).

Trial Locations

Locations (1)

Tobacco Dependence Research Unit; 🇬🇧 London, United Kingdom