Contact information
Type
Scientific
Primary contact
Dr Mike Franklin
ORCID ID
Contact details
BMS
Oxford Brookes University
Oxford
OX3 OBP
United Kingdom
michael.franklin@psych.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BMS2/05
Study information
Scientific title
Acronym
SJW
Study hypothesis
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
Approved by the local NHS Oxfordshire Ethics Committee
Study design
2 x 2 phase II randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
St John's wort
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
21/02/2006
Overall trial end date
31/08/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
144
Participant 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
Recruitment start date
21/02/2006
Recruitment end date
31/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
BMS
Oxford
OX3 OBP
United Kingdom
Sponsor information
Organisation
Oxford Brookes University (UK)
Sponsor details
Gipsy Lane
Headington
Oxford
OX3 OBP
United Kingdom
jfrancis@brookes.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK)
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19328636
Publication citations
-
Results
Parsons A, Ingram J, Inglis J, Aveyard P, Johnstone E, Brown K, Franklin M, Bermudez I, A proof of concept randomised placebo controlled factorial trial to examine the efficacy of St John's wort for smoking cessation and chromium to prevent weight gain on smoking cessation., Drug Alcohol Depend, 2009, 102, 1-3, 116-122, doi: 10.1016/j.drugalcdep.2009.02.006.