Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01414998

Acronym

SenRep

Enrollment

120

Registered

2011-08-11

Start date

2012-05-31

Completion date

2013-03-31

Last updated

2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Withdrawal

Brief 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 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.

Interventions

BEHAVIORALStress Ball vs Nicotine-free E-Cigarette

In 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.

BEHAVIORALNicotine-free E-Cigarette vs De-nicotinised Cigarette

In 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Urge to smoke at 10 minutes post product use	10 minutes	Urges to smoke will be measured at 10 minutes after use of products

Secondary

Measure	Time frame	Description
Tobacco withdrawal symptom ratings over one day	1 day	Change in tobacco withdrawal symptom ratings over a day
Tobacco withdrawal symptom ratings over 1 hour	1 hour	Change withdrawal ratings one hour after product use

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026