A 2 x 2 phase II randomised controlled trial to investigate the efficacy of St John's wort versus placebo in smoking cessation and the efficacy of chromium intake in preventing weight gain

ISRCTN	ISRCTN31302738
DOI	https://doi.org/10.1186/ISRCTN31302738
Protocol serial number	BMS2/05
Sponsor	Oxford Brookes University (UK)
Funder	Cancer Research UK (UK)

Submission date: 08/02/2006
Registration date: 24/02/2006
Last edited: 18/01/2012

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mike Franklin
Scientific

BMS
Oxford Brookes University
Oxford
OX3 OBP
United Kingdom

Email	michael.franklin@psych.ox.ac.uk

Study information

Primary study design	Interventional
Study design	2 x 2 phase II randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SJW
Study objectives	Our hypothesis is that St John's wort (SJW) will help people to stop smoking through its effects on dopamine, acetylcholine nicotinic receptors and serotonin to reduce the symptoms that occur following quitting and that chromium will reduce weight gain following quitting through its effects on insulin sensitivity.
Ethics approval(s)	Approved by the local NHS Oxfordshire Ethics Committee
Health condition(s) or problem(s) studied	Smoking cessation
Intervention	Patients are randomised to receive one of the following interventions: 1. SJW and chromium 2. Chromium and placebo 3. SJW and placebo 4. Control: placebo and placebo
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	St John's wort
Primary outcome measure(s)	For SJW, primary outcome will be quitting at four weeks post quit, the standard for the NHS. For chromium, primary outcome will be weight change as defined by week 4 minus week 0 weight.
Key secondary outcome measure(s)	Relating to SJW, secondary outcomes include: 1. Side-effects of SJW withdrawal symptoms 2. Changes in State Trait Anxiety Inventory (STAI) 3. Questionnaire of Smoking Urges (QSU) brief 4. Mood and Physical Symptoms Scale (MPSS) questionnaires 5. Changes in salivary cortisol profile, plasma prolactin and free tryptophan For chromium, secondary outcomes include: 1. Changes in food frequency questionnaire 2. Metabolic changes that might follow from changes in carbohydrate and lipid metabolism as a result of chromium. These are free tryptophan, Non-Esterified Free Fatty Acids (NEFFAs), Large Neutral Amino Acids (LNAAs), triglycerides and change in body fat estimated through bioimpedance.
Completion date	31/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	144
Key inclusion criteria	Smokers 18 or over that want to stop smoking in the next two weeks and that have smoked at least 10 cigarettes per day for the past year and are clinically suitable to take SJW and chromium.
Key exclusion criteria	1. Pregnant women and breast-feeding women, or women who plan a pregnancy while on medication 2. Severe liver impairment 3. Current depression or moderate to severe depression within last six months 4. People with a past history of eating disorders 5. People with a past history of psychotic disorder 6. People with a history of alcohol or illegal drug use within the past six months 7. People taking medication that may interact with SJW
Date of first enrolment	21/02/2006
Date of final enrolment	31/08/2006

Locations

Countries of recruitment

United Kingdom

Study participating centre

BMS

Oxford
OX3 OBP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No