Trial record 1 of 3 for:    Clinical Trial Methods for Assessing a Tobacco Product
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Methods Project 4: Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01867242
First received: May 29, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This is a multi-center trial involving the University of Minnesota, Ohio State University Comprehensive Cancer Center, and Roswell Park Cancer. Cigarette smokers who are eligible will enter a Camel Snus sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then be randomized to one of the five experimental conditions for 8 weeks. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.


Condition Intervention Phase
Smoker
Other: Cigarettes
Other: Snus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: PROJECT 4: CLINICAL TRIAL METHODS FOR ASSESSING A TOBACCO PRODUCT Part of "MODELS FOR TOBACCO PRODUCT EVALUATION

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Pattern of Tobacco Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of use of camel snus and use of cigarettes will be compared between groups.


Secondary Outcome Measures:
  • Nicotine Biomarker Exposure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Nicotine exposure and metabolite ratio (NMR) and the total nicotine equivalents will be determined.

  • Carbon Monoxide Exposure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Exhaled carbon monoxide (CO) and oxygen saturation as indicators of the extent to which red blood cells may be carrying their usual load of oxygen.

  • Carcinogen Biomarker of Exposure [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Carcinogen biomarkers (NNAL, NNN, mercapturic acids) of exposure and effect were chosen because they have shown reasonable laboratory reproducibility, have clear differences in levels between smokers and nonsmokers and/or decrease upon tobacco cessation.


Estimated Enrollment: 793
Study Start Date: July 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual Brand Cigarette
Smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus and instructed for partial or complete substitution of cigarettes (subject's choice);
Other: Cigarettes
Smoke their usual brand of cigarettes and follow their normal patterns of use.
Experimental: Complete Substitution Ad libitum
Complete substitution (i.e., no smoking) and snus use ad libitum
Other: Snus
Winterchill or Robust flavors
Other Name: Camel Snus
Experimental: Partial Substitution (Snus and Cigarettes) Ad libitium
Partial substitution of snus for cigarettes and snus use is ad libitum
Other: Cigarettes
Smoke their usual brand of cigarettes and follow their normal patterns of use.
Other: Snus
Winterchill or Robust flavors
Other Name: Camel Snus
Experimental: Partial Substitution (Snus and Cigarettes) with Instructions
Partial substitution with instructions for the use of snus and ad libitum smoking.
Other: Cigarettes
Smoke their usual brand of cigarettes and follow their normal patterns of use.
Other: Snus
Winterchill or Robust flavors
Other Name: Camel Snus
Experimental: Complete Substitutuion with Insruction
Complete substitution (no conventional cigarettes) with instruction given for snus use.
Other: Snus
Winterchill or Robust flavors
Other Name: Camel Snus

Detailed Description:

Baseline smoking period: Subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured including a record of their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR).

Experimental Period: After the baseline assessment, subjects will be randomized to one of five experimental conditions: 1) smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus to use as they will for 8 more weeks; 2) complete substitution (i.e., no smoking) and ad libitum use of snus; 3) complete substitution (i.e., no smoking) and specific instructions for snus; 4) partial substitution with ad libitum use of both snus and cigarettes; and 5) partial substitution with controlled use of snus and ad libitum smoking. Snus, but not cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects who are at least 18 years of age;
  • Daily smoker;
  • Generally good health;
  • Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products);

Exclusion Criteria:

  • Unstable health
  • Pregnant or breastfeeding (due to toxic effects from tobacco products).
  • Unable to read for comprehension or completion of study documents.
  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: NCT01867242

Contacts
Contact: Dorothy Hatsukami, M.D. 612-626-2121 hatsu002@umn.edu
Contact: Joni Jensen 612-624-5178 jense010@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Dorothy Hatsukami, M.D.    612-626-2121    hatsu001@umn.edu   
Principal Investigator: Dorothy Hatsukami, M.D.         
United States, New York
Roswell Park Cancer Center Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Richard O'Connor, Ph.D.         
Principal Investigator: Richard O'Connor, Ph.D.         
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Peter Shields, M.D.         
Principal Investigator: Peter Shields, M.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dorothy Hatsukami, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01867242     History of Changes
Other Study ID Numbers: 2012NTLS050
Study First Received: May 29, 2013
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
cigarette
snus
smoking
tobacco

ClinicalTrials.gov processed this record on October 30, 2014