Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 250
- Primary Endpoint
- Changes in the exhaled carbon monoxide (CO) level during the 12-week study
Study Overview
Brief Summary
Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes for NRT in subgroups of smokers. The investigators evaluated the efficacy and safety of sublingual nicotine tablets (SNT) for smoking cessation and the association of catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial among Chinese smokers.
Detailed Description
All subjects provided written informed consent after a full explanation of the protocol design.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects motivated to stop smoking and Han Chinese
- •aged 20-70 years who lived in the Haidian District of Beijing
- •smoke ≥10 cigarettes/day
- •have smoked for ≥3 years
- •carbon monoxide (CO) level ≥10 p.p.m. in exhaled air
Exclusion Criteria
- •a history of "Diagnostic and Statistical Manual of Mental Disorders-fourth Edition" (DSM-IV) psychiatric disorder
- •alcohol abuse and other drug abuse
- •with pathological changes in the floor of their mouth
- •cardiovascular disease
- •taking psychotropic medications
- •using other forms of tobacco or any other NRT products during the last 6 months
- •pregnant or breast-feeding
Arms & Interventions
sublingual nicotine，placebo
sublingual nicotine：one or two tablets per hour, up to a maximum of 20 tablets per day Subjects were advised to use the full treatment dose for 4 weeks
Intervention: sublingual nicotine (Drug)
Outcomes
Primary Outcomes
Changes in the exhaled carbon monoxide (CO) level during the 12-week study
Time Frame: The first was 1 day before quit day (baseline), followed by visits after 1, 2, 4, 6 and 8 weeks at the end of treatment (EOT), with a final follow-up visit at 12 weeks.
Secondary Outcomes
No secondary outcomes reported