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

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980550
• Other study ID #: Hongqiang-2010
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2011
• Last updated: November 10, 2013
• Start date: March 2004
• Est. completion date: December 2004

Study information

• Verified date: November 2013
• Source: National Institute on Drug Dependence, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Dependence, China	Bronx VA Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes