Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00710034
First received: July 2, 2008
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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 and negative affect from cigarette abstinence, but smokers who are assigned to the oral tobacco product will be more likely to report liking the effects from their assigned product compared to those smokers assigned to medicinal nicotine; 2) greater physiological effects (e.g., vitals) will be observed for the oral tobacco product compared to medicinal nicotine; 3) 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; 4) although the abstinence rates will be higher for oral tobacco products, and initial product costs will be lower, relative to the medicinal nicotine intervention, the likelihood of longer duration of oral tobacco use will increase the oral tobacco cost over time for the user; and 5) switching to low-nitrosamine oral tobacco will reduce life-years lost compared to continuing smoking and will be a cost-effective (in terms of life-years saved) substitution strategy compared to medicinal nicotine.


Condition Intervention Phase
Tobacco Use Disorder
Other: Oral tobacco
Drug: Nicotine Gum
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Smoking Cessation and Among Non-abstainers, for Reduction in Cigarette Smoking

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Product effect on complete substitution for smoking [ Time Frame: 2, 4, 12, 26 and 52 week post smoking cessation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Products effect on withdrawal symptoms, affective symptoms, and product evaluation. [ Time Frame: Week 1-12 post switching ] [ Designated as safety issue: No ]
  • Product effect on vital signs. [ Time Frame: Week 1-12 ] [ Designated as safety issue: No ]
  • Product effect on biomarkers of exposure and toxicity [ Time Frame: Week 4 and 12 post smoking cessation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: April 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nicotine Gum
Nicotine replacement therapy
Drug: Nicotine Gum
4 mg Nicotine gum
Other Name: Nicorette
Experimental: Snus
Oral tobacco
Other: Oral tobacco
Snus
Other Name: Camel Snus

Detailed 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. If the sample size is sufficient, then comparisons will be made across products on these measures while controlling for amount of tobacco use. Other secondary aims include examining the reliability of our biological measures in a control group that continues to smoke, the extent of constituent extraction after oral pouch tobacco use, the relationship between extent of constituent extraction and biomarkers of exposure, and finally, withdrawal symptoms from the oral tobacco products. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00710034

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00710034     History of Changes
Other Study ID Numbers: 1R01 CA135884-2, 1R01CA135884
Study First Received: July 2, 2008
Last Updated: October 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Oral Tobacco Products
Snus
Smoking Substitution
Harm Reduction
Biomarkers of Tobacco Exposure

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014