Condition category
Mental and Behavioural Disorders
Date applied
30/04/2007
Date assigned
24/05/2007
Last edited
03/03/2015
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

Dr Michael Ussher

ORCID ID

Contact details

Division of Community Health Sciences
St George's University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)20 8725 5605
mussher@sgul.ac.uk

Additional identifiers

EudraCT number

2007-002203-40

ClinicalTrials.gov number

Protocol/serial number

7.0056

Study information

Scientific title

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

Acronym

Study hypothesis

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

Wandsworth Research Ethics Committee, 20/07/2007, ref: 07/Q0803/97

Study design

Randomised double-blind placebo-controlled study, within-subject balanced cross-over design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Hydrocortisone

Primary outcome measures

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 trial start date

01/12/2007

Overall trial end date

30/11/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/12/2007

Recruitment end date

30/11/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's University of London
London
SW17 0RE
United Kingdom

Sponsor information

Organisation

St George's University of London (UK)

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)20 8725 5000
awithers@sgul.ac.uk

Sponsor type

University/education

Website

https://portal.sgul.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (ref: C8641/A8419)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21301812

Publication citations

Additional files

Editorial Notes