A Phase 4 interventional study of sublingual nicotine in Nicotine Dependence, sponsored by National Institute on Drug Dependence, China. Completed. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-11-13.
Sponsored by National Institute on Drug Dependence, China · Phase 4 and Interventional
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.
All subjects provided written informed consent after a full explanation of the protocol design.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 250 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →National Institute on Drug Dependence, China is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Also known as: nicotine sublingual tablet
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.
No study locations are listed for this record.
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Dependence, China