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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dunja Przulj, Queen Mary University of London

ClinicalTrials.gov Identifier:

NCT01414998

First received: August 10, 2011

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 10, 2011

Last Updated Date

March 19, 2013

Start Date ^ICMJE

May 2012

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Urge to smoke at 10 minutes post product use [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Urges to smoke will be measured at 10 minutes after use of products

Original Primary Outcome Measures ^ICMJE

Urge to smoke at 10 minutes post product use. [ Designated as safety issue: No ]

The primary outcome measure is comparison of cue-induced urges to smoke at 10 minutes post product use, between the nicotine-free EC and stress ball condition in Study 1, and between the Denic and nicotine-free EC in Study 2.

Change History

Complete list of historical versions of study NCT01414998 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Tobacco withdrawal symptom ratings over 1 hour [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Change withdrawal ratings one hour after product use
Tobacco withdrawal symptom ratings over one day [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Change in tobacco withdrawal symptom ratings over a day

Original Secondary Outcome Measures ^ICMJE

Tobacco withdrawal symptom ratings over 1 hour [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Comparison between the EC and stress ball in Study 1 and EC and Denic in Study 2, on tobacco withdrawal symptom ratings over 1 hour.
Tobacco withdrawal symptom ratings over one day [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Comparison between the EC and stress ball in Study 1, and EC and Denic in Study 2, on tobacco withdrawal symptom ratings following a days use.
Product ratings and preferences [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Comparison between the EC and stress ball in Study 1, and EC and Denic in Study 2, on product ratings (satisfaction, helpfullness, user acceptability) and preferences following a days use.
Interactions between level of behavioural dependence and efficacy of products [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Sensorimotor Replacement With Electronic and De-nicotinised Cigarettes

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Nicotine Withdrawal

Intervention ^ICMJE

Behavioral: 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.
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.

Study Arm (s)

Active Comparator: Stress Ball
This is the active comparator for study 1

Intervention: Behavioral: Stress Ball vs Nicotine-free E-Cigarette
Experimental: De-nicotinised Cigarette
This will be the experimental arm for study 2

Intervention: Behavioral: Nicotine-free E-Cigarette vs De-nicotinised Cigarette
Experimental: Nicotine-free Electronic Cigarette (1)
This will be the experimental arm for study 1

Intervention: Behavioral: Stress Ball vs Nicotine-free E-Cigarette
Active Comparator: Nicotine-free Electronic Cigarette (2)
This will be the active comparator for study 2

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

120

Completion Date

March 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01414998

Other Study ID Numbers ^ICMJE

qmul1606

Has Data Monitoring Committee

Responsible Party

Dunja Przulj, Queen Mary University of London

Study Sponsor ^ICMJE

Queen Mary University of London

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dunja Przulj

Queen Mary University of London

Information Provided By

Queen Mary University of London

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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