Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy

Phase 4

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: sublingual nicotine

• Registration Number: NCT01980550
• Lead Sponsor: National Institute on Drug Dependence, China

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 Timeline

• Study Start: 2004-03
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2011-04-13
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-04
• Last Update Submitted: 2013-11-10
• Study First Posted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sublingual nicotine，placebo	sublingual nicotine	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

Primary Outcome Measures

Name	Time	Method
Changes in the exhaled carbon monoxide (CO) level during the 12-week study	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.