Smoking CessationDenicNCT01250301
De-nicotinised Cigarettes Study
A study testing De-nicotinised cigarettes + standard treatment and Standard Treatment in people with Smoking Cessation and Tobacco Dependence, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Dependence
- What is being tested?
- De-nicotinised cigarettes + standard treatment and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or over
- Seeking treatment to stop smoking
Who cannot join
- Pregnant or breastfeeding
- Acute psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complementing Current NHS Stop Smoking Service Treatments for Smokers With Behavioural Replacement: The Role of De-nicotinised Cigarettes
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
- Being tested
- De-nicotinised cigarettes + standard treatment, Standard Treatment
- Keywords
- Smoking Cessation, Tobacco Dependence, De-nicotinised cigarettes
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-nicotinised cigarettes + standard treatmentOther
Also called NHS Stop Smoking Service, De-nicotinised cigarettes
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 TreatmentOther
Participants will receive standard treatment from the NHS Stop Smoking Service.
| Study group | Role | What they receive |
|---|---|---|
| De-nicotinised cigarettes + standard treatment | Experimental | Not described Receives: Other: De-nicotinised cigarettes + standard treatment |
| Standard treatment | Active comparator | Not described Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 week
Secondary outcomes (6)
Change in ratings of tobacco withdrawal symptoms, measured by the MPSS
Measured: First 4 weeks of abstinence (from baseline- 4 weeks post-quit)
CO-validated continuous abstinence rates
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.
Measured: 4-weeks
Acceptability and user reactions to DNCs
Measured: 2 weeks
Urges to smoke 24 hours after quitting, measured by the MPSS
Measured: 24 hours
Profile of adverse effects up to 12 weeks post quitting
Measured: 12 weeks
Reactions to smoking cues
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJul 2011
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Hayden McRobbie, Queen Mary University of London
- Investigators
- Hayden McRobbie, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250301
- Sponsor's protocol ID
- qmul200910
- Acronym
- Denic
- Status last verified
- Jul 2012
- First submitted
- 29 Nov 2010
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementing Current NHS Stop Smoking Service Treatments for Smokers With Behavioural Replacement: The Role of De-nicotinised Cigarettes
- ClinicalTrials.gov ID
- NCT01250301
- Acronym / sponsor ID
- Denic / qmul200910
- Conditions
- Smoking Cessation, Tobacco Dependence
- Keywords
- Smoking Cessation, Tobacco Dependence, De-nicotinised cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De-nicotinised cigarettes + standard treatment | Experimental | Other: De-nicotinised cigarettes + standard treatment |
| Standard treatment | Active comparator | Other: Standard Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or over
- Seeking treatment to stop smoking
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding
- Acute psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De-nicotinised cigarettes + standard treatmentAlso: NHS Stop Smoking Service, De-nicotinised cigarettesParticipants 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). | Other | De-nicotinised cigarettes + standard treatment |
| Standard TreatmentParticipants will receive standard treatment from the NHS Stop Smoking Service. | Other | Standard treatment |
Primary outcome
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).
6 secondary outcomes
Change in ratings of tobacco withdrawal symptoms, measured by the MPSS
Time frame: First 4 weeks of abstinence (from baseline- 4 weeks post-quit)
CO-validated continuous abstinence rates
Time frame: 4-weeks
Acceptability and user reactions to DNCs
Time frame: 2 weeks
Urges to smoke 24 hours after quitting, measured by the MPSS
Time frame: 24 hours
Profile of adverse effects up to 12 weeks post quitting
Time frame: 12 weeks
Reactions to smoking cues
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayden McRobbie principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De-nicotinised cigarettes + standard treatment and Standard Treatment in people with Smoking Cessation and Tobacco Dependence, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urges to smoke in first week of abstinence (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.