| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN31302738 |
| Date ISRCTN assigned | 24/02/2006 |
| Local reference number(s) | BMS2/05 |
| Public title | 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 |
| Scientific title |
|
| Acronym | SJW |
| Disease/condition/study domain | Smoking |
| 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 |
| Design/methodology | Randomised double-blind and placebo controlled trial |
| Research ethics review | This was approved by the local NHS Oxfordshire Ethics Committee |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 21/02/2006 |
| Anticipated end date | 31/08/2006 |
| Status of trial | Completed |
| Target number of participants | 144 |
| Interventions | 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 |
| 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. |
| 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. |
| Sources of funding | Cancer Research UK |
| Sponsor name | Oxford Brookes University (UK) |
| Sponsor details | Gipsy Lane
Headington
Oxford
United Kingdom
OX3 OBP |
| Sponsor email | jfrancis@brookes.ac.uk |
| Contact name | Dr Mike Franklin |
| Contact details | BMS
Oxford Brookes University
Oxford
United Kingdom
OX3 OBP |
| Contact email | michael.franklin@psych.ox.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN31302738 |
| Date last extracted from ISRCTN register | 17/04/2008 |
