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

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.

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

All subjects provided written informed consent after a full explanation of the protocol design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sublingual nicotine

Drug

The nicotine sublingual tablet is Smokers were recommended to use 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. After this time-point, treatment could be tapered off up to the 8-week visit. During the next 4-week follow-up phase, no further medication was dispensed. Staff, who dispensed medications, were not involved in treating the subjects. During each patient visit, the importance of adequate dosing with study medication was emphasized. The medication was free of charge. In addition, all participants received six sessions of standardized behavioral group counseling focusing on self-monitoring and behavioral modification approaches.

Other names: nicotine sublingual tablet

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.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Dependence, China

Other

Collaborators

Bronx VA Medical Center

Registry information

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Nov 11, 2013
Registry last updated: Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed