Methods Project 4: Clinical Trial

Not Applicable

Completed

• Conditions: Smoker
• Interventions: Other: Cigarettes; Other: Snus

• Registration Number: NCT01867242
• Lead Sponsor: University of Minnesota

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-06-03
• Study Start: 2013-07
• Primary Completion: 2017-02
• Study Completion: 2018-05
• Results First Submitted: 2022-05-04
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-24
• Results First Posted: 2023-04-25
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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);

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partial Substitution (Snus and Cigarettes)	Snus	Use snus and cigarettes how ever you like
Complete Substitution	Snus	Use snus in place of cigarettes
Partial Substitution (Snus and Cigarettes)	Cigarettes	Use snus and cigarettes how ever you like
Usual Brand Cigarette	Cigarettes	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);

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Urinary Total NNAL	8 weeks	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)
Total Nicotine Exposure	8 weeks	Urinary total nicotine equivalents, the molar sum of nicotine and six metabolites, accounts for more than 90% of a nicotine dose
CEMA (2-cyanoethylmercapturic Acid)	8 weeks	2-cyanoethylmercapturic acid (CEMA) is a biomarker for exposure to acrylonitrile, a volatile organic compound, and is sensitive to changes in cigarette smoke exposure.

Trial Locations

Locations (3)

Roswell Park Cancer Center; 🇺🇸 Buffalo, New York, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States