The effect of hydrocortisone on desire to smoke and tobacco withdrawal symptoms

ISRCTN	ISRCTN81211851
DOI	https://doi.org/10.1186/ISRCTN81211851
EudraCT/CTIS number	2007-002203-40
Secondary identifying numbers	7.0056

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Michael Ussher
Scientific

Division of Community Health Sciences
St George's University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

Phone	+44 (0)20 8725 5605
Email	mussher@sgul.ac.uk

Study design	Randomised double-blind placebo-controlled study, within-subject balanced cross-over design
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	The effect of hydrocortisone on desire to smoke and tobacco withdrawal symptoms
Study objectives	That giving oral hydrocortisone (on the first day of smoking abstinence), may significantly reduce the desire to smoke and reduce tobacco withdrawal symptoms among temporarily abstinent smokers, relative to a placebo.
Ethics approval(s)	Wandsworth Research Ethics Committee, 20/07/2007, ref: 07/Q0803/97
Health condition(s) or problem(s) studied	Nicotine dependence/smoking cessation
Intervention	40 mg hydrocortisone (HC) versus 20 mg HC versus placebo. Each participant will only receive a single dose of each treatment on waking and will be followed-up just on the afternoon after they have taken the tablet.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Hydrocortisone
Primary outcome measure	Reports of desire to smoke and tobacco withdrawal, these will be measured prior to abstinence on waking and then after two hours, four hours and six hours. On each of the three treatment days these symptoms will be measured at the same time points.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/12/2007
Completion date	30/11/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	50
Key inclusion criteria	1. Male and female smokers aged 18 to 65 years 2. Have been smoking at least ten cigarettes a day for at least three years
Key exclusion criteria	1. Those receiving psychiatric treatment 2. Those currently taking corticosteroids 3. Those with cautions for using oral corticosteroids will also be excluded as follows: 3.1. Pregnant 3.2. Planning a pregnancy or breastfeeding 3.3. Heart problems 3.4. Patient suffers from tuberculosis or has had it in the past 3.5. Stomach ulcer or other digestive problem 3.6. Shingles or a herpes infection in the eye 3.7. Muscle weakness (myopathy) after using steroids in the past 3.8. Diabetic 3.9. High blood pressure 3.10. Glaucoma 3.11. Corneal perforation 3.12. Significant impairment of renal or liver function 3.12. Myasthenia gravis 3.14. Osteoporosis 3.15. Thyroid problems 3.16. Epilepsy
Date of first enrolment	01/12/2007
Date of final enrolment	30/11/2008

St George's University of London

London
SW17 0RE
United Kingdom

St George's University of London (UK)
University/education

Cranmer Terrace
London
SW17 0RE
England
United Kingdom

Charity

Cancer Research UK (ref: C8641/A8419)
Private sector organisation / Other non-profit organizations

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2011		Yes	No