Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/8/2017 |
| Start Date: | April 2010 |
| End Date: | May 2014 |
Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking
For the primary goals, we hypothesize that 1) the oral tobacco product will be more
efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2)
among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette
smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal
nicotine use will be observed during and beyond the treatment period.
For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal
symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced
dramatically when smokers switch from cigarettes to each of these products; however, this
reduction will be greater with the use of medicinal nicotine.
efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2)
among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette
smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal
nicotine use will be observed during and beyond the treatment period.
For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal
symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced
dramatically when smokers switch from cigarettes to each of these products; however, this
reduction will be greater with the use of medicinal nicotine.
This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial.
Subjects will be randomized to the brand of smokeless tobacco that is determined to be most
effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for
smoking. The secondary aims are to determine the effects of the products on biomarkers of
exposure and toxicity. Other secondary aim includes examining the effects of the two products
on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and
Oregon Research Institute (ORI).
Subjects will be randomized to the brand of smokeless tobacco that is determined to be most
effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for
smoking. The secondary aims are to determine the effects of the products on biomarkers of
exposure and toxicity. Other secondary aim includes examining the effects of the two products
on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and
Oregon Research Institute (ORI).
Inclusion Criteria:
- smoking at least 10 cigarettes daily for the past year,
- in good physical health (no unstable medical condition;
- no contraindications for medicinal nicotine, as appropriate for the study, stable,
good mental health (e.g., no recent unstable or untreated psychiatric diagnosis,
including substance abuse, as determined by the DSM-IV criteria).
Exclusion Criteria:
Subjects must not be currently using other tobacco or nicotine products; Female subjects
cannot be pregnant or nursing.
We found this trial at
2
sites
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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