De-nicotinised Cigarettes Study

NCT01250301 | Completed

• 1 other identifier: qmul200910
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Tobacco Dependence

Keywords

Smoking Cessation; Tobacco Dependence; De-nicotinised cigarettes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

Study Arms (2)

De-nicotinised cigarettes + standard treatment

EXPERIMENTAL

Other: De-nicotinised cigarettes + standard treatment

Standard treatment

ACTIVE COMPARATOR

Other: Standard Treatment

Interventions

De-nicotinised cigarettes + standard treatment 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).

Also known as: NHS Stop Smoking Service, De-nicotinised cigarettes

De-nicotinised cigarettes + standard treatment

Standard Treatment OTHER

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

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or over
• Seeking treatment to stop smoking

You may not qualify if:

• Pregnant or breastfeeding
• Acute psychiatric illness

Sponsors & Collaborators

• Queen Mary University of London: lead
• Pfizer: collaborator

Study Sites (1)

Tobacco Dependence Research Unit

London, E1 2JH, United Kingdom

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hayden McRobbie

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hayden McRobbie

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: November 30, 2010
• Study Start: July 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

GB (1)