Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

NCT ID: NCT01414998

Last Updated: 2013-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-03-31

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.

Conditions

Nicotine Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stress Ball

This is the active comparator for study 1

Group Type: ACTIVE_COMPARATOR

Stress Ball vs Nicotine-free E-Cigarette

Intervention Type: BEHAVIORAL

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.

De-nicotinised Cigarette

This will be the experimental arm for study 2

Group Type: EXPERIMENTAL

Nicotine-free E-Cigarette vs De-nicotinised Cigarette

Intervention Type: BEHAVIORAL

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.

Nicotine-free Electronic Cigarette (1)

This will be the experimental arm for study 1

Group Type: EXPERIMENTAL

Stress Ball vs Nicotine-free E-Cigarette

Intervention Type: BEHAVIORAL

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.

Nicotine-free Electronic Cigarette (2)

This will be the active comparator for study 2

Group Type: ACTIVE_COMPARATOR

Nicotine-free E-Cigarette vs De-nicotinised Cigarette

Intervention Type: BEHAVIORAL

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.

Interventions

Stress 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.

Intervention Type: BEHAVIORAL

Nicotine-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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Dunja Przulj

Prinicipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dunja Przulj

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

Tobacco Dependence Research Unit

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

qmul1606

Identifier Type: -

Identifier Source: org_study_id