Complementing Current NHS Stop Smoking Service Treatments for Smokers With Behavioural Replacement: The Role of De-nicotinised Cigarettes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Urges to smoke in first week of abstinence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years or over
- •Seeking treatment to stop smoking
Exclusion Criteria
- •Pregnant or breastfeeding
- •Acute psychiatric illness
Arms & Interventions
De-nicotinised cigarettes + standard treatment
Intervention: De-nicotinised cigarettes + standard treatment (Other)
Standard treatment
Intervention: Standard Treatment (Other)
Outcomes
Primary Outcomes
Urges to smoke in first week of abstinence
Time Frame: 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 Outcomes
- 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)
- Reactions to smoking cues(12 weeks)
Investigators
Hayden McRobbie
Dr. Hayden McRobbie
Queen Mary University of London