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De-nicotinised Cigarettes Study (Denic)

Q

Queen Mary University of London

Status

Completed

Conditions

Tobacco Dependence
Smoking Cessation

Treatments

Other: De-nicotinised cigarettes + standard treatment
Other: Standard Treatment

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01250301
qmul200910

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18 years or over
  • Seeking treatment to stop smoking

Exclusion criteria

  • Pregnant or breastfeeding
  • Acute psychiatric illness

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

De-nicotinised cigarettes + standard treatment
Experimental group
Treatment:
Other: De-nicotinised cigarettes + standard treatment
Standard treatment
Active Comparator group
Treatment:
Other: Standard Treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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