Condition category
Mental and Behavioural Disorders
Date applied
15/10/2008
Date assigned
27/10/2008
Last edited
10/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Sally Playle

ORCID ID

Contact details

University of Surrey
Faculty of Arts & Human Sciences
Department of Psychology
Guildford
GU2 7XH
United Kingdom
+44 (0)1483 300800
sg00014@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC/3008/21/FHS

Study information

Scientific title

Investigation to explore whether there is a synergistic effect between nicotine replacement therapy and guided bodyscanning on cigarette cravings and withdrawal symptoms

Acronym

Study hypothesis

The research aims to determine whether there is a synergistic effect between the relaxation technique of guided bodyscanning and nicotine replacement therapy (NRT) in reducing cigarette cravings and withdrawal symptoms in temporarily abstinent smokers.

Ethics approval

The University of Surrey Ethics Committee gave approval on the 1st May 2008. An application is also being prepared for submission to the National Research Ethics Service (NRES) for ethical review before the end of October 2008.

Study design

A randomised single-blind placebo-controlled, single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Smoking cessation

Intervention

Participants will be randomly allocated to receive either
1. Active nicotine patch plus:
1.1. Guided bodyscanning audio
1.2. Passive control audio (a natural history text reading)
2. Placebo patch plus:
2.1. Guided bodyscanning audio
2.2. Passive control audio (a natural history text reading)

Those who are assigned to the active nicotine patch conditions will complete a Fagerström Test for Nicotine Dependence (FTND) and depending on their individual level of dependence will be administered with either a 14 mg or 21 mg transdermal NiQuitin nicotine replacment patch at the beginning of the trial to be kept on for a maximum of 7 hours.

Participation in all potential arms of the trial will last for a maximum of 7 hours. There will be no follow up period as the study is a brief lab-based intervention.

Intervention type

Drug

Phase

Not Applicable

Drug names

Nicotene replacement therapy

Primary outcome measures

Strength of desire to smoke and tobacco withdrawal symptoms will be measured using the self-report 7-point Mood and Physical Symptoms Scale (MPSS), whereby 1 = 'not at all', 4 = 'somewhat' and 7 = 'extremely'.

All ratings will be made on a pre-programmed palmtop computer which will prompt participants to ratings at:
1. 10 am: Single set of ratings in the presence of the researcher
2. 11 am: Single set of ratings in your natural environment
3. 12 pm: Multiple rating at the intervals detailed below
4. Between 1 pm and 4 pm (if necessary): Multiple ratings at the intervals detailed below:
Rating 1 (just before audio)
Audio (10 minutes)
Rating 2 (just after audio)
Rating 3 (5 minutes after audio)
Rating 4 (20 minutes after audio)
Rating 5 (30 minutes after audio)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2009

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Smokers
2. Aged 18 to 65 years, either sex
3. Consume at least 10 cigarettes a day, and have done for at least the last three consecutive years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Receiving treatment for mental health problems
2. Pregnant
3. Currently trying to conceive

Recruitment start date

01/01/2009

Recruitment end date

30/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Surrey
Guildford
GU2 7XH
United Kingdom

Sponsor information

Organisation

University of Surrey (UK)

Sponsor details

c/o Professor Terry Desombre
School of Management
Guildford
GU2 7XH
United Kingdom
+44 (0)1483 686367
t.desombre@surrey.ac.uk

Sponsor type

University/education

Website

http://www.som.surrey.ac.uk/profile/details.aspx?id=368

Funders

Funder type

University/education

Funder name

University of Surrey (UK)

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/05/2016: No publications found, verifying study status with principal investigator.