Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00711100
First received: July 2, 2008
Last updated: October 26, 2009
Last verified: October 2009
  Purpose

Recently, tobacco companies have developed new oral tobacco products that are purportedly less harmful than conventional tobacco products. These products have not been tested by independent research for their health effects or consumer palatability. In addition, it is not known if these products will be used in addition to cigarette smoking or as a substitute to cigarettes. These two studies will examine four oral tobacco products to answer some of these questions.

The goals of this first study will be to examine: 1) the brand of oral tobacco products which is preferred by cigarette smokers and the pattern and amount of product use when used as a cessation tool; 2) the characteristics that are associated with product choice; 3) toxicant exposure from these products; and 4) the withdrawal symptoms from the tobacco products and potential for continued use.

Specifically, our primary aims hypothesize that: 1) the product that will be chosen by most smokers will be based on taste and sensory aspects of the product with products higher in nicotine content more likely to be chosen as the preferred product; and 2) subjects will experience no difficulty using the product for cessation, but a small minority will engage in dual product use.

For the secondary aims, we hypothesize: 1) that compared to the subjects' own brand of cigarettes, the biomarkers for exposure and toxicity for the oral tobacco products will be significantly lower; 2) products will vary in exposure to toxicants while subjects are using the products naturalistically; 3) biomarkers will be significantly related to the amount of constituents extracted by the user; 4) withdrawal symptoms from the oral products are likely to occur, but are likely to be mild compared to cigarette withdrawal.


Condition Intervention Phase
Tobacco Use Disorder
Other: Product Preference
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study 1: Preference, Health Effects and Efficacy of Four Oral Tobacco Products for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Product preference [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Smoking cessation [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nicotine levels [ Time Frame: 2 weeks on product ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Camel Snus
Other: Product Preference
Subjects will sample each product for 1/2 day and choose one product to use for smoking cessation.
Experimental: 2
Marlboro Snus
Other: Product Preference
Subjects will sample each product for 1/2 day and choose one product to use for smoking cessation.
Experimental: 4
Stonewall
Other: Product Preference
Subjects will sample each product for 1/2 day and choose one product to use for smoking cessation.
Experimental: 3
Ariva
Other: Product Preference
Subjects will sample each product for 1/2 day and choose one product to use for smoking cessation.
Experimental: 5.
General Snus
Other: Product Preference
Subjects will sample each product for 1/2 day and choose one product to use for smoking cessation.

Detailed Description:

This observational study will be accomplished by allowing subjects to sample the products and choose one oral tobacco product that they will use instead of cigarettes for a two week period. After the two weeks, they will discontinue all tobacco use and withdrawal symptoms and abstinence rates will be observed. Smokers who are uninterested in quitting will be recruited to continue to smoke at their normal rate and attend only the visits where urine samples are collected for biomarker analysis.

Subjects will attend an orientation visit where the study will be explained in detail. Interested subjects will sign a consent form and be scheduled to return for baseline measures. Subjects will have a review of medical history to verify that they are in generally good health and do not have contraindications to the study products. Eligible subjects will collect one week of baseline measures while smoking at their normal rate: measures include daily diaries of smoking, questionnaires and urine samples. At the second baseline visit, they will receive samples of the oral tobacco products. The tobacco products tested are five novel oral products recently introduced to the market: 1) Camel Snus (higher nicotine); 2) General Snus (higher nicotine); 3) Marlboro Snus (lower nicotine); and two compressed tobacco tablets, 4) Ariva (lower nicotine), or 5) Stonewall (higher nicotine). All of these tobacco products are purported to have reduced levels of tobacco-specific nitrosamines, one of the tobacco carcinogens.

During sample weeks, subjects will be given 10 pouches/tablets of each product and instructed to use at least three of the daily products in the morning of sample day and resume smoking in the afternoon and through the following day. They will sample the next product in a similar manner. This will allow a short, but adequate trial of each product to determine preference. After the sampling weeks, subjects will choose the product they will want to use to quit smoking. They will be supplied that product over the next two weeks.

During the two weeks of product use during smoking cessation, subjects will come to weekly clinic visits and then a follow-up visits at 1 week and a phone call at 4 weeks after the end of treatment. At baseline, and 2 weeks post quit, subjects will bring in a urine sample from their first morning void and bloods will be drawn. These samples will be analyzed for tobacco-related biomarkers. An additional spot urine sample will be collected after the first week of product use and analyzed for nicotine and its metabolites. At each visit, subjects will have vital signs obtained (blood pressure, heart rate, weight and carbon monoxide level), they will complete several subjective forms regarding tobacco use, withdrawal symptoms, and mood. Subjects will receive brief behavioral counseling for smoking cessation at all visits.

In addition, during the sample weeks and at the end of two weeks of study product use, subjects will submit three used chews that will be sent to CDC to be analyzed for the tobacco constituents.

  Eligibility

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

Inclusion Criteria:

  • Cigarette smokers who smoke 10 or more cigarettes per day
  • Generally good health

Exclusion Criteria:

  • Unstable medical or psychiatric condition.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711100

Contacts
Contact: Joni Jensen, MPH 612-624-5178 jense010@umn.edu
Contact: Amanda Anderson, BA 612-624-5178 ander411@umn.edu

Locations
United States, Minnesota
Univeristy of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Joni Jensen, MPH    612-624-5178    jense010@umn.edu   
Contact: Amanda Anderson, BA    612-627-1821    ander411@umn.edu   
Principal Investigator: Dorothy Hatsukami, Ph.D.         
United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 47404
Contact: Herb Severson, Ph.D.    541-484-2123    herb@ori.org   
Principal Investigator: Herb Severson, Ph.D.         
Sponsors and Collaborators
Investigators
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Dorothy Hatsukami, University of Minnesota
ClinicalTrials.gov Identifier: NCT00711100     History of Changes
Other Study ID Numbers: 1R01 CA135884, Study 1
Study First Received: July 2, 2008
Last Updated: October 26, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Smoking cessation
Oral tobacco products

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014