Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

NCT00711100 | Completed Results DMC

• 2 other identifiers: 0712M223431R01CA135884
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

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 switching tool; 2) the characteristics that are associated with product choice; 3) nicotine exposure from these products; and 4) the withdrawal symptoms from the tobacco products and potential for continued use. Specifically, our primary aims hypotheses were: 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 complete cigarette substitution, but a small minority will engage in dual product use. For the secondary aims, we hypothesized: 1) that compared to the subjects' own brand of cigarettes, the biomarkers for exposure for the oral tobacco products will be significantly lower; 2) withdrawal symptoms from the oral products are likely to occur, but are likely to be mild compared to cigarette withdrawal.

Conditions

Tobacco Use Disorder

Keywords

Substitution for cigarettes; Oral tobacco products

Outcome Measures

Primary Outcomes (2)

• Product Preference

  Number of individuals who selected each of the products (e.g., Camel Snus, Marlboro Snus, General Snus, Ariva, Stonewall).

  2 weeks

• Abstinence From Cigarettes

  Abstinence from cigarettes during Abstinence Phase.

  Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up)

Study Arms (5)

Camel Snus

EXPERIMENTAL

Camel Snus (oral smokeless tobacco product). Dosage: 1.74-1.97 mg nicotine per portion.

Other: Camel Snus

Marlboro Snus

EXPERIMENTAL

Marlboro Snus (oral smokeless tobacco product). Dosage: 0.14 - 0.38 mg nicotine per portion.

Other: Marlboro Snus

Stonewall

EXPERIMENTAL

Stonewall (oral dissolvable tobacco product). Dosage: 0.28-0.57 mg nicotine per portion.

Other: Stonewall

Ariva

EXPERIMENTAL

Ariva (oral dissolvable tobacco product). Dosage: 0.24-0.25 mg nicotine per portion.

Other: Ariva

General Snus

EXPERIMENTAL

General Snus (oral smokeless tobacco product); Dosage: 3.37 mg nicotine.

Other: General Snus

Interventions

Camel Snus OTHER

All subjects will sample Camel Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Camel Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Camel Snus is chosen for use) during abstinence phase.

Camel Snus

Marlboro Snus OTHER

All subjects will sample Marlboro Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Marlboro Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Marlboro Snus is chosen for use) during abstinence phase.

Marlboro Snus

Stonewall OTHER

All subjects will sample Stonewall and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Stonewall. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Stonewall is chosen for use) during abstinence phase.

Stonewall

Ariva OTHER

All subjects will sample Ariva and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of Ariva. Intervention period (duration: 2 weeks) involves ad libitum daily use (if Ariva is chosen for use) during abstinence phase.

Ariva

General Snus OTHER

All subjects will sample General Snus and determine if they would prefer to use this product during the abstinence phase over the other products sampled. Sampling period (duration: 1/2 day) requires use of at least 3 samples of General Snus. Intervention period (duration: 2 weeks) involves ad libitum daily use (if General Snus is chosen for use) during abstinence phase.

General Snus

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Unstable medical or psychiatric condition.

Sponsors & Collaborators

• University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Univeristy of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Oregon Research Institute

Eugene, Oregon, 47404, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

stwl protein, Drosophila

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dorothy Hatsukami, Ph.D.
• Organization: University_of_Minnesota

hatsu001@umn.edu

612-626-2121

Study Officials

• Dorothy Hatsukami, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label trial
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 8, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2010
• Last Updated: November 18, 2019
• Results First Posted: September 16, 2015

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)