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

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ClinicalTrials.gov Identifier: NCT01980550
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : November 13, 2013
Sponsor:
Collaborator:
Bronx VA Medical Center
Information provided by (Responsible Party):
National Institute on Drug Dependence, China

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: sublingual nicotine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Official Title: Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy
Study Start Date : March 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.
Other Name: nicotine sublingual tablet




Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980550


Sponsors and Collaborators
National Institute on Drug Dependence, China
Bronx VA Medical Center
Investigators
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Principal Investigator: xiang y zhang, professor VA Medical Center,USA

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Responsible Party: National Institute on Drug Dependence, China
ClinicalTrials.gov Identifier: NCT01980550     History of Changes
Other Study ID Numbers: Hongqiang-2010
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action