sing genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact upon adherence
- Conditions
- Smoking addiction
- Registration Number
- EUCTR2006-000106-24-GB
- Lead Sponsor
- Kings College London (IOP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 633
Inclusion Criteria
1. Regular cigarette smokers, defined as those smoking an average of 10 or more cigs/day (including roll-ups) over the preceding 12 months, who want to stop smoking
2. Aged 18 years or older,
3. Male or female
4. Able to give informed consent to participate.
5. Able to complete, either alone or with assistance, the study questionnaires
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.Cigar, pipe and oral tobacco users who do not also smoke 10 or more cigarettes per day.
2.Those who meet contraindications for NRT use as described in the Summary Product Characteristics. Although not all forms of NRT is not contra-indicated in pregnancy or lactation, the metabolism of nicotine changes and there remain concerns about safety in this group (being specifically addressed in a current RCT). Therefore pregnant or lactating women or those who plan to get pregnant during the course of treatment will be excluded. .
3.Those with previous severe adverse reactions to NRT patch or to oral NRT.
4.Currently taking medication for smoking cessation that they are unwilling to cease taking or medication with a known influence on smoking cessation that they cannot stop (e.g. nortriptyline for depression).
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