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Trial record 17 of 58 for:    Taste Disorders | NIH

Evaluation of Oral Tobacco as a Harm Reduction Method for Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00711100
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : September 16, 2015
Last Update Posted : May 12, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Interventions: Other: Camel Snus
Other: Marlboro Snus
Other: Stonewall
Other: Ariva
Other: General Snus

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited 10/2008 through 8/2009 through local advertisements in Minnesota and Oregon.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sampling Phase preceded the 2 week Abstinence Phase. Sampling phase involved sampling each study product for a 1/2 day; subjects then chose the product that they would like to use for a two week cigarette abstinence period

Reporting Groups
Oral Tobacco Products Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva

Participant Flow:   Overall Study
    Oral Tobacco Products
STARTED   104 
Lack of Efficacy                5 
Withdrawal by Subject                8 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Oral Tobacco Products Camel Snus, Marlboro Snus, General Snus, Stonewall, Ariva

Baseline Measures
   Oral Tobacco Products 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      2   1.9% 
Between 18 and 65 years      97  93.3% 
>=65 years      5   4.8% 
[Units: Years]
Mean (Standard Deviation)
 40.1  (13.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      40  38.5% 
Male      64  61.5% 
Region of Enrollment 
[Units: Participants]
United States   104 

  Outcome Measures

1.  Primary:   Product Preference   [ Time Frame: 2 weeks ]

2.  Primary:   Abstinence From Cigarettes   [ Time Frame: Survival (abstinence) at 3 weeks (2 weeks intervention and 1 week follow-up) ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dorothy Hatsukami, Ph.D.
Organization: University_of_Minnesota
phone: 612-626-2121
e-mail: hatsu001@umn.edu

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00711100     History of Changes
Other Study ID Numbers: Study 1
1R01CA135884 ( U.S. NIH Grant/Contract )
First Submitted: July 2, 2008
First Posted: July 8, 2008
Results First Submitted: October 17, 2013
Results First Posted: September 16, 2015
Last Update Posted: May 12, 2017