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

N

National Institute on Drug Dependence, China

Status and phase

Completed
Phase 4

Conditions

Nicotine Dependence

Treatments

Drug: sublingual nicotine

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01980550
Hongqiang-2010

Details and patient eligibility

About

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.

Full description

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

Enrollment

250 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

sublingual nicotine,placebo
Experimental group
Description:
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
Treatment:
Drug: sublingual nicotine

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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