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”

For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in smoking; 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 nicotine gum 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) cessation strategy compared to medicinal nicotine.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2012

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 popular in Study 1 or to nicotine gum for 12 weeks to compare efficacy for smoking cessation.

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).

Intervention(s) in this Clinical Trial

• Other: Oral tobacco
  • To be determined by Study 1
• Drug: Nicotine replacement
  • 4 mg Nicotine gum

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Nicotine replacement therapy
• Experimental: 2
  • Oral tobacco

Primary Measures

• Smoking cessation
  • Time Frame: 12, 13, 26 and 52 week post smoking cessation
    Safety Issue?: No

Secondary Measures

• Products effect on withdrawal symptoms, affective symptoms, and product evaluation.
  • Time Frame: Week 1-13 post smoking cessation
    Safety Issue?: No
• Product effect on vital signs.
  • Time Frame: Week 1-13
    Safety Issue?: No
• Product effect on biomarkers of exposure and toxicity
  • Time Frame: Week 4 and 12 post smoking cessation
    Safety Issue?: Yes

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, d) 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Dorothy Hatsukami, Ph.D. Principal Investigator University of Minnesota  

Overall Contact: Joni A Jensen, MPH 612-627-4903 jense010@umn.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00710034

Study ID Number: Study 2

ClinicalTrials.gov Identifier: NCT00710034

Health Authority: United States: Federal Government