Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes (SenRep)

Queen Mary University of London

Status: Completed

Conditions: Nicotine Withdrawal

Treatments: Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette; Behavioral: Stress Ball vs Nicotine-free E-Cigarette

Study type: Interventional

Funder types: Other

Identifiers

NCT01414998

qmul1606

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Stress Ball

Active Comparator group

Description:

This is the active comparator for study 1

Treatment:

Behavioral: Stress Ball vs Nicotine-free E-Cigarette

De-nicotinised Cigarette

Experimental group

Description:

This will be the experimental arm for study 2

Treatment:

Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette

Nicotine-free Electronic Cigarette (1)

Experimental group

Description:

This will be the experimental arm for study 1

Treatment:

Behavioral: Stress Ball vs Nicotine-free E-Cigarette

Nicotine-free Electronic Cigarette (2)

Active Comparator group

Description:

This will be the active comparator for study 2

Treatment:

Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette