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Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

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ClinicalTrials.gov Identifier: NCT00710034
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

July 2, 2008
July 3, 2008
November 30, 2016
December 6, 2017
December 6, 2017
April 2010
May 2013   (Final data collection date for primary outcome measure)
  • Product Effect on Complete Substitution for Smoking [ Time Frame: 6 week post smoking substitution ]
    Number of subjects using only the assigned study product at week 6
  • Number of Cigarettes Smoked [ Time Frame: 6 weeks post cigarette substitution ]
    Cigarettes per day at mid intervention
  • Number of Products Used [ Time Frame: 6 weeks post smoking substitution ]
    Pieces of product per week at mid intervention
Smoking cessation [ Time Frame: 12, 13, 26 and 52 week post smoking cessation ]
Complete list of historical versions of study NCT00710034 on ClinicalTrials.gov Archive Site
  • Products Effect on Withdrawal Symptoms. [ Time Frame: Week 1-12 post switching ]
    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.
  • Product Effect on Biomarkers of Exposure and Toxicity [ Time Frame: Baseline and Week 4 post smoking substitution ]
    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).
  • Products effect on withdrawal symptoms, affective symptoms, and product evaluation. [ Time Frame: Week 1-13 post smoking cessation ]
  • Product effect on vital signs. [ Time Frame: Week 1-13 ]
  • Product Effect on Biomarkers of Exposure and Toxicity [ Time Frame: Week 4 and 12 post smoking cessation ]
Not Provided
Not Provided
 
Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
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.

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).
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
This was an open label trial.
Primary Purpose: Treatment
Tobacco Use Disorder
  • Other: Oral tobacco
    Snus
    Other Name: Camel Snus
  • Drug: Nicotine Gum
    4 mg Nicotine gum
    Other Name: Nicorette
  • Active Comparator: Nicotine Gum
    Nicotine replacement therapy (4 mg nicotine gum) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute nicotine gum for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.
    Intervention: Drug: Nicotine Gum
  • Experimental: Snus
    Oral tobacco (Camel Snus) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute snus for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.
    Intervention: Other: Oral tobacco
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
391
400
May 2014
May 2013   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00710034
1R01 CA135884-2
1R01CA135884 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: We will share data with both internal and external researchers. Those external researchers interested in accessing the data will be required to submit a data analyses proposal with specific aims, hypotheses, and data analyses plan. These proposals will be reviewed by the investigative team. The requested data will then be provided that includes the variable list, raw data and description of the measures and methods of data collection.
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP