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 |
| Secondary identifying numbers | BMS2/05 |
- 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
Scientific
BMS
Oxford Brookes University
Oxford
OX3 OBP
United Kingdom
| michael.franklin@psych.ox.ac.uk |
Study information
| Study design | 2 x 2 phase II randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | St John's wort |
| Primary outcome measure | 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 study start date | 21/02/2006 |
| Completion date | 31/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
OX3 OBP
United Kingdom
Sponsor information
Oxford Brookes University (UK)
University/education
University/education
Gipsy Lane
Headington
Oxford
OX3 OBP
United Kingdom
| jfrancis@brookes.ac.uk | |
"ROR" |
https://ror.org/04v2twj65 |
Funders
Funder type
Charity
Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2009 | Yes | No |
