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

NCT ID: NCT01980550

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-12-31

Brief Summary

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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

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

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

sublingual nicotine

Intervention Type 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.

Interventions

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sublingual nicotine

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.

Intervention Type DRUG

Other Intervention Names

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nicotine sublingual tablet

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bronx VA Medical Center

FED

Sponsor Role collaborator

National Institute on Drug Dependence, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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xiang y zhang, professor

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center，USA

Other Identifiers

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Hongqiang-2010

Identifier Type: -

Identifier Source: org_study_id