Health Effects of SLT, Cigarette Smoking, and New Tobacco Products

NCT00469079 | Completed Phase 2 Results DMC

• 2 other identifiers: 010M79961P50DA013333
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The use of smokeless tobacco (ST) as a substitute for cigarette smoking has been suggested since it is considered by some to be a less harmful tobacco product (Russell, Jarvis and Feyerabend, 1980; Russell et al, 1981; Rodu, 1994). ST does not have the volatile constituents and carbon monoxide (CO) that are found in cigarette smoke. Since ST is not smoked there would be less risk of cardiovascular and lung disease. In addition the harm associated with second hand smoke would be eliminated. Although the health risks are reduced in ST users, they still exist due to the presence of nitrosamines found in ST. A better approach would be to use nicotine replacement that did not contain carcinogens, however the cost of such NRT could be prohibitive especially in third world countries where the rate of smoking is continuing to rise and the per capita income is much lower than in the United States. Purpose: The goal of this study is to evaluate the health effects of Camel Snus, the new oral tobacco product produced by RJ Reynolds and Taboka, produced by Phillip Morris. These products are pasteurized rather than fermented and contain less moisture to eliminate spitting. They are marketed as an alternative to cigarette smoking.

Conditions

Nicotine Dependence

Keywords

Biomarkers; Smoking; Tobacco; Cessation

Outcome Measures

Primary Outcomes (3)

• Toxicant Exposure by Products

  Levels of carcinogen biomarkers (NNAL) reported as difference between baseline and week 4 scores.

  Baseline, 4 weeks

• Product Use at Week 4 of Intervention

  Self-reported daily use of the assigned study product. Range of scores is from 0 to about 20. Higher scores do not represent either a better or a worse outcome. Higher number of product used per day may indicate higher abuse liability of the product but may lead to a greater suppression in usual brand cigarette smoking. Lower number of product use per day may indicate lower abuse liability but may lead to lower suppression of usual brand smoking.

  4 weeks

• Abstinence From Tobacco at End of Treatment, 1 Week and 11 Weeks Post-intervention.

  This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected at each visit to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the end of treatment and at each of the 2 follow-up visits (week 1 and 11 post-intervention). Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report (i.e., no cigarettes smoked) and confirmed by an exhaled CO of less than 8 ppm. At the follow-up visits, abstinence was also confirmed by both exhaled CO concentrations and urinary cotinine concentration (\<35 ng/mL).

  12 weeks

Secondary Outcomes (1)

• Product Effect on Craving and Nicotine Withdrawal Symptoms at 1 Week.

  Baseline and 1 week

Study Arms (3)

1

ACTIVE COMPARATOR

Nicotine gum or nicotine lozenge; Dosage: 2 or 4 mg; Frequency: Daily; Duration: 5 weeks of use of which 1 week is tapering.

Drug: Nicotine gum and lozenge

2

EXPERIMENTAL

Taboka - oral tobacco product Dosage: 0.84 to 1.26 mg free nicotine per g dry weight; Frequency: Daily; Duration: 5 weeks of use of which 1 week is tapering.

Other: Taboka

3

EXPERIMENTAL

Camel Snus - oral tobacco product Dosage: 6.09 to 9.16 mg dry weight; Frequency: Daily; Duration: 5 weeks of use of which 1 week is tapering.

Other: Camel Snus

Interventions

Nicotine gum and lozenge DRUG

Nicotine replacement

Also known as: Commit, Nicorette

1

Taboka OTHER

smokeless tobacco product

2

Camel Snus OTHER

smokeless tobacco product

3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects between 18-70 years of age
• Smoking at least 10 cigarettes/day for at least one year
• Good physical and mental health as evidenced by a medical history with no unstable medical conditions.

You may not qualify if:

• Uncontrolled chronic disease or condition that requires medical attention during the course of the study
• Contraindications for nicotine replacement products: active ulcers, recent heart attack, heart disease or irregular heart beat, uncontrolled high blood pressure, or medication use that might affect tobacco use
• Current unstable psychiatric diagnoses or persons who currently are adjusting medication dose. (within the last 3 months)
• Subjects with current or recent (within 6 months) alcohol or drug abuse problem
• Other regular tobacco use such as regular cigar or pipe smoking
• Currently using other nicotine replacement products
• Chronic use of any drug that could interact with the study drugs.

Sponsors & Collaborators

• University of Minnesota: lead
• National Cancer Institute (NCI): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Tobacco Use Research Center

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (1)

• Kotlyar M, Hertsgaard LA, Lindgren BR, Jensen JA, Carmella SG, Stepanov I, Murphy SE, Hecht SS, Hatsukami DK. Effect of oral snus and medicinal nicotine in smokers on toxicant exposure and withdrawal symptoms: a feasibility study. Cancer Epidemiol Biomarkers Prev. 2011 Jan;20(1):91-100. doi: 10.1158/1055-9965.EPI-10-0349. Epub 2010 Nov 10.

  PMID: 21068204 BACKGROUND

Related Links

• Kotlyar M, Mendoza-Baumgart MI, Li ZZ, et al. Nicotine pharmacokinetics and subjective effects of three potential reduced exposure products, moist snuff and nicotine lozenge. Tob Control 2007;16:138-42.

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Nicotine Chewing Gum; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Smokeless tobacco products commercially available have been introduced, withdrawn, or changed at a relatively rapid rate resulting in products that are no longer available and changes that occurred during the time period that the study occurred.

Results Point of Contact

• Title: Dorothy Hatsukami, Ph.D.
• Organization: University of Minnesota

hatsu001@umn.edu

612-626-2121

Study Officials

• Dorothy Hatsukami, PHD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: January 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: November 1, 2019
• Results First Posted: April 14, 2014

Record last verified: 2019-10

Locations

US (1)