Nicotine WithdrawalSenRepNCT01414998
Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes
A study testing Stress Ball vs Nicotine-free E-Cigarette and Nicotine-free E-Cigarette vs De-nicotinised Cigarette in people with Nicotine Withdrawal, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
There are currently two sensorimotor replacement products which may be of benefit in smoking cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the purpose of this project is to investigate whether these replacements can help to alleviate tobacco withdrawal symptoms in smokers, during a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Withdrawal
- What is being tested?
- Stress Ball vs Nicotine-free E-Cigarette and Nicotine-free E-Cigarette vs De-nicotinised Cigarette
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Mar 2013
- 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
- Smokes at least 10 cigarettes per day
- Smokes first cigarette within 1 hour of waking
Who cannot join
- pregnant or breastfeeding
- acute psychiatric illness
- currently enrolled in other research projects
- current use of ECs or Denics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes
There are currently two sensorimotor replacement products which may be of benefit in smoking cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the purpose of this project is to investigate whether these replacements can help to alleviate tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be separated into two studies, following the same design and procedures.
Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool (e.g. stress ball) which provides no smoking-related cues.
Read more
Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement which only delivers some of the conditioned sensorimotor cues (i.e. ECs).
The investigators hypothesise that the EC will be more effective at reducing withdrawal symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the Denic will be more effective than the EC.
- Conditions
- Nicotine Withdrawal
- Being tested
- Stress Ball vs Nicotine-free E-Cigarette, Nicotine-free E-Cigarette vs De-nicotinised Cigarette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Ball vs Nicotine-free E-CigaretteBehavioural
In a cross over design, participants will be randomly allocated to:
- use a stress ball for 5 minutes during a 1 hour controlled experiment. They will also use the stress ball for one day outside of the study centre.
- use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre.
One week later participants will complete the other arm.
Nicotine-free E-Cigarette vs De-nicotinised CigaretteBehavioural
In a cross over design, participants will be randomly allocated to:
- use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre.
- smoke 1 de-nicotinised cigarette during a 1 hour controlled experiment. They will also be given a pack to smoke ad-libitum for one day outside of the study centre.
One week later participants will complete the other arm.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball | Active comparator | This is the active comparator for study 1 Receives: Behavioral: Stress Ball vs Nicotine-free E-Cigarette |
| De-nicotinised Cigarette | Experimental | This will be the experimental arm for study 2 Receives: Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette |
| Nicotine-free Electronic Cigarette (1) | Experimental | This will be the experimental arm for study 1 Receives: Behavioral: Stress Ball vs Nicotine-free E-Cigarette |
| Nicotine-free Electronic Cigarette (2) | Active comparator | This will be the active comparator for study 2 Receives: Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urge to smoke at 10 minutes post product use
Urges to smoke will be measured at 10 minutes after use of products
Measured: 10 minutes
Secondary outcomes (2)
Tobacco withdrawal symptom ratings over 1 hour
Change withdrawal ratings one hour after product use
Measured: 1 hour
Tobacco withdrawal symptom ratings over one day
Change in tobacco withdrawal symptom ratings over a day
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine WithdrawalStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dunja Przulj, Queen Mary University of London
- Investigators
- Dunja Przulj, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414998
- Sponsor's protocol ID
- qmul1606
- Acronym
- SenRep
- Status last verified
- Mar 2013
- First submitted
- 10 Aug 2011
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes
- ClinicalTrials.gov ID
- NCT01414998
- Acronym / sponsor ID
- SenRep / qmul1606
- Conditions
- Nicotine Withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Aug 2011 (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.
There are currently two sensorimotor replacement products which may be of benefit in smoking cessation: de-nicotinised cigarettes (denics) and electronic cigarettes (ECs), and the purpose of this project is to investigate whether these replacements can help to alleviate tobacco withdrawal symptoms in smokers, during a period of abstinence. This project will be separated into two studies, following the same design and procedures.
Study 1 will seek to confirm the importance of sensorimotor cues by comparing the efficacy of a nicotine-free EC in alleviating withdrawal symptoms, to a behavioural distraction tool (e.g. stress ball) which provides no smoking-related cues.
Study 2 will investigate whether sensorimotor replacements which are more proximal to smoking (i.e. Denics), will be more effective in alleviating withdrawal symptoms than a replacement which only delivers some of the conditioned sensorimotor cues (i.e. ECs).
The investigators hypothesise that the EC will be more effective at reducing withdrawal symptoms compared to the stress ball in Study 1. In Study 2, it is hypothesised that the Denic will be more effective than the EC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stress Ball | Active comparator | Behavioral: Stress Ball vs Nicotine-free E-CigaretteThis is the active comparator for study 1 |
| De-nicotinised Cigarette | Experimental | Behavioral: Nicotine-free E-Cigarette vs De-nicotinised CigaretteThis will be the experimental arm for study 2 |
| Nicotine-free Electronic Cigarette (1) | Experimental | Behavioral: Stress Ball vs Nicotine-free E-CigaretteThis will be the experimental arm for study 1 |
| Nicotine-free Electronic Cigarette (2) | Active comparator | Behavioral: Nicotine-free E-Cigarette vs De-nicotinised CigaretteThis will be the active comparator for study 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or over
- Smokes at least 10 cigarettes per day
- Smokes first cigarette within 1 hour of waking
Key exclusion criteria (4 listed)
- pregnant or breastfeeding
- acute psychiatric illness
- currently enrolled in other research projects
- current use of ECs or Denics
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 |
|---|---|---|
| Stress Ball vs Nicotine-free E-CigaretteIn a cross over design, participants will be randomly allocated to: 1. use a stress ball for 5 minutes during a 1 hour controlled experiment. They will also use the stress ball for one day outside of the study centre. 2. use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre. One week later participants will complete the other arm. | Behavioural | Nicotine-free Electronic Cigarette (1), Stress Ball |
| Nicotine-free E-Cigarette vs De-nicotinised CigaretteIn a cross over design, participants will be randomly allocated to: 1. use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre. 2. smoke 1 de-nicotinised cigarette during a 1 hour controlled experiment. They will also be given a pack to smoke ad-libitum for one day outside of the study centre. One week later participants will complete the other arm. | Behavioural | De-nicotinised Cigarette, Nicotine-free Electronic Cigarette (2) |
Primary outcome
Urge to smoke at 10 minutes post product use
Time frame: 10 minutes
Urges to smoke will be measured at 10 minutes after use of products
2 secondary outcomes
Tobacco withdrawal symptom ratings over 1 hour
Time frame: 1 hour
Tobacco withdrawal symptom ratings over one day
Time frame: 1 day
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 20 Mar 2013.
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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.
Dunja Przulj 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 Stress Ball vs Nicotine-free E-Cigarette and Nicotine-free E-Cigarette vs De-nicotinised Cigarette in people with Nicotine Withdrawal, 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 3 inclusion and 4 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 20 Mar 2013. 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?
Urge to smoke at 10 minutes post product use (time frame: 10 minutes). 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 20 Mar 2013.