A 2x2 phase II randomized controlled trial to investigate the efficacy of NRT plus St John's wort versus NRT plus placebo in smoking cessation and to examine the efficacy of chromium nicotinate versus placebo in preventing weight gain while stopping smoking. - SJW and chromium in smoking cessatio
- Conditions
- Stopping smoking.
- Registration Number
- EUCTR2005-000662-39-GB
- Lead Sponsor
- Oxford Brookes University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 144
All smokers 18 years or over that want to stop smoking and that have smoked at least 10 cigarettes per day for the past year. Clinically suitable to take NRT, SJW, and Cr.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Pregnant and breast feeding women, or women that are planning pregnancy while they would be scheduled to be on medication
2) Severe liver impairment
3) Current depression or recent moderate-severe depression (checked using the two screening questions recommended by NICE and by current use of antidepressant medication or past use during the past two years.
4) People taking some antidepressants, antipsychotics, immunosupressants, digoxin, the pill, methadone (see exclusion list)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method