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De-nicotinised Cigarettes Study

NCT ID: NCT01250301

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

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.

Detailed Description

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Conditions

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Smoking Cessation Tobacco Dependence

Keywords

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Smoking Cessation Tobacco Dependence De-nicotinised cigarettes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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De-nicotinised cigarettes + standard treatment

Group Type EXPERIMENTAL

De-nicotinised cigarettes + standard treatment

Intervention Type 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).

Standard treatment

Group Type ACTIVE_COMPARATOR

Standard Treatment

Intervention Type OTHER

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

Interventions

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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).

Intervention Type OTHER

Standard Treatment

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

Intervention Type OTHER

Other Intervention Names

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NHS Stop Smoking Service De-nicotinised cigarettes

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Hayden McRobbie

Dr. Hayden McRobbie

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hayden McRobbie

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

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Tobacco Dependence Research Unit

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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qmul200910

Identifier Type: -

Identifier Source: org_study_id