CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Nicotine gum and lozenge +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00469079
NCT00469079Phase 2Completed

Comparing the Health Effects of Smokeless Tobacco, Cigarette Smoking, and New Tobacco Products Advertised as Safer Alternatives Part of Tobacco Exposure Reduction

University of Minnesota·interventional·Posted May 4, 2007·Updated Nov 1, 2019

In Brief

A Phase 2 clinical trial evaluating Nicotine gum and lozenge, Taboka, and 1 other intervention for Nicotine Dependence. Completed, enrolled 130 participants across 1 site.

Detailed Summary

The use of smokeless tobacco (ST) as a substitute for cigarette smoking has been suggested since it is considered by some to be a less harmful tobacco product (Russell, Jarvis and Feyerabend, 1980; Russell et al, 1981; Rodu, 1994). ST does not have the volatile constituents and carbon monoxide (CO) that are found in cigarette smoke. Since ST is not smoked there would be less risk of cardiovascular and lung disease. In addition the harm associated with second hand smoke would be eliminated. Although the health risks are reduced in ST users, they still exist due to the presence of nitrosamines found in ST. A better approach would be to use nicotine replacement that did not contain carcinogens, however the cost of such NRT could be prohibitive especially in third world countries where the rate of smoking is continuing to rise and the per capita income is much lower than in the United States. Purpose: The goal of this study is to evaluate the health effects of Camel Snus, the new oral tobacco product produced by RJ Reynolds and Taboka, produced by Phillip Morris. These products are pasteurized rather than fermented and contain less moisture to eliminate spitting. They are marketed as an alternative to cigarette smoking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2007
Enrollment StartJan 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.2 years ago

Interventions

Nicotine gum and lozengedrug

Nicotine replacement

Tabokaother

smokeless tobacco product

Camel Snusother

smokeless tobacco product