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 gai

Completed

Conditions: Smoking cessation
Mental and Behavioural Disorders

Registration Number: ISRCTN31302738

Lead Sponsor: Oxford Brookes University (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 144

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.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Relating to SJW, secondary outcomes include:<br>1. Side-effects of SJW withdrawal symptoms<br>2. Changes in State Trait Anxiety Inventory (STAI)<br>3. Questionnaire of Smoking Urges (QSU) brief<br>4. Mood and Physical Symptoms Scale (MPSS) questionnaires<br>5. Changes in salivary cortisol profile, plasma prolactin and free tryptophan<br><br><br>For chromium, secondary outcomes include:<br>1. Changes in food frequency questionnaire<br>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.