Methods Project 4: Clinical Trial

PROJECT 4: CLINICAL TRIAL METHODS FOR ASSESSING A TOBACCO PRODUCT Part of "MODELS FOR TOBACCO PRODUCT EVALUATION

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 three experimental conditions for 8 weeks. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.

Study Overview

• Status: Completed
• Conditions: Smoker
• Intervention / Treatment: Other: Cigarettes; Other: 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 use snus instead ; 3) partial substitution - use of both snus and cigarettes as you like. 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Use snus in place of cigarettes	Other: Snus; Winterchill or Robust flavors; Other Names: Camel Snus
Experimental: Partial Substitution (Snus and Cigarettes); Use snus and cigarettes how ever you like	Other: Cigarettes; Smoke their usual brand of cigarettes and follow their normal patterns of use.; Other: Snus; Winterchill or Robust flavors; Other Names: Camel Snus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoke-free Days	Number of days subjects smoked no cigarettes during the intervention was compared between groups.	8 weeks (56 (+/-5) days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CEMA (2-cyanoethylmercapturic Acid)	2-cyanoethylmercapturic acid (CEMA) is a biomarker for exposure to acrylonitrile, a volatile organic compound, and is sensitive to changes in cigarette smoke exposure.	8 weeks
Total Nicotine Exposure	Urinary total nicotine equivalents, the molar sum of nicotine and six metabolites, accounts for more than 90% of a nicotine dose	8 weeks
Urinary Total NNAL	Urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL) is a metabolite of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), one of the group of chemicals termed tobacco-specific N-nitrosamines (TSNA)	8 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 3, 2013

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: smoking; tobacco; cigarette; snus
• Other Study ID Numbers: 2012NTLS050; 5U19CA157345 (U.S. NIH Grant/Contract)