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

ISRCTN	ISRCTN52104724
DOI	https://doi.org/10.1186/ISRCTN52104724
Secondary identifying numbers	EC/3008/21/FHS

Submission date: 15/10/2008
Registration date: 27/10/2008
Last edited: 10/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Sally Playle
Scientific

University of Surrey
Faculty of Arts & Human Sciences
Department of Psychology
Guildford
GU2 7XH
United Kingdom

Phone	+44 (0)1483 300800
Email	sg00014@surrey.ac.uk

Study information

Study design	A randomised single-blind placebo-controlled, single-centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Investigation to explore whether there is a synergistic effect between nicotine replacement therapy and guided bodyscanning on cigarette cravings and withdrawal symptoms
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Nicotene replacement therapy
Primary outcome measure	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 study start date	01/01/2009
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	72
Key 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
Key exclusion criteria	1. Receiving treatment for mental health problems 2. Pregnant 3. Currently trying to conceive
Date of first enrolment	01/01/2009
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Surrey

Guildford
GU2 7XH
United Kingdom

Sponsor information

University of Surrey (UK)
University/education

c/o Professor Terry Desombre
School of Management
Guildford
GU2 7XH
England
United Kingdom

Phone	+44 (0)1483 686367
Email	t.desombre@surrey.ac.uk
Website	http://www.som.surrey.ac.uk/profile/details.aspx?id=368
"ROR"	https://ror.org/00ks66431

Funders

Funder type

University/education

University of Surrey (UK)
Private sector organisation / Universities (academic only)

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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