Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Non-nicotine Sensorimotor Replacement on Withdrawal and Craving: Studies With Electronic and De-nicotinised Cigarettes

Conditions
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Nicotine Withdrawal

Intervention / Treatment
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* Behavioral: Stress Ball vs Nicotine-free E-Cigarette
* Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or over Smokes at least 10 cigarettes per day Smokes first cigarette within 1 hour of waking Exclusion Criteria: pregnant or breastfeeding acute psychiatric illness currently enrolled in other research projects current use of ECs or Denics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stress Ball<br>This is the active comparator for study 1 | Behavioral: Stress Ball vs Nicotine-free E-Cigarette<br>* 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.<br>|
| Experimental: De-nicotinised Cigarette<br>This will be the experimental arm for study 2 | Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette<br>* 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.<br>|
| Experimental: Nicotine-free Electronic Cigarette (1)<br>This will be the experimental arm for study 1 | Behavioral: Stress Ball vs Nicotine-free E-Cigarette<br>* 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.<br>|
| Active Comparator: Nicotine-free Electronic Cigarette (2)<br>This will be the active comparator for study 2 | Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urge to smoke at 10 minutes post product use | Urges to smoke will be measured at 10 minutes after use of products | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco withdrawal symptom ratings over 1 hour | Change withdrawal ratings one hour after product use | 1 hour | 
| Tobacco withdrawal symptom ratings over one day | Change in tobacco withdrawal symptom ratings over a day | 1 day |