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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31302738

Enrollment

144

Registered

2006-02-24

Start date

2006-02-21

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking cessation Mental and Behavioural Disorders Smoking cessation

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026