Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710034
• Other study ID #: 1R01 CA135884-2
• Secondary ID: 1R01CA135884
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2008
• Last updated: October 31, 2017
• Start date: April 2010
• Est. completion date: May 2014

Study information

• Verified date: October 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Other:
• Oral tobacco
Snus

Drug:
• Nicotine Gum
4 mg Nicotine gum

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hatsukami DK, Severson H, Anderson A, Vogel RI, Jensen J, Broadbent B, Murphy SE, Carmella S, Hecht SS. Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching. Tob Control. 2016 May;25(3):267-74. doi: 10.1136/tobaccocontrol-2014-052080. Epub 2015 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product Effect on Complete Substitution for Smoking	Number of subjects using only the assigned study product at week 6	6 week post smoking substitution
Primary	Number of Cigarettes Smoked	Cigarettes per day at mid intervention	6 weeks post cigarette substitution
Primary	Number of Products Used	Pieces of product per week at mid intervention	6 weeks post smoking substitution
Secondary	Products Effect on Withdrawal Symptoms.	Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.	Week 1-12 post switching
Secondary	Product Effect on Biomarkers of Exposure and Toxicity	Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).	Baseline and Week 4 post smoking substitution