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

NCT01980550 | Completed Phase 4

• 1 other identifier: Hongqiang-2010
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

sublingual nicotine，placebo

EXPERIMENTAL

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

Drug: sublingual nicotine

Interventions

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.

Also known as: nicotine sublingual tablet

sublingual nicotine，placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Dependence, China: lead
• Bronx VA Medical Center: collaborator

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• xiang y zhang, professor

  VA Medical Center，USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: November 11, 2013
• Study Start: March 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: November 13, 2013

Record last verified: 2013-11