Methods Project 4: Clinical Trial

Smoker Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867242
• Other study ID #: 2012NTLS050
• Secondary ID: 5U19CA157345
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: May 2018

Study information

• Verified date: April 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoker

Intervention

Other:
• Cigarettes
Smoke their usual brand of cigarettes and follow their normal patterns of use.
• Snus
Winterchill or Robust flavors

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoke-free Days	Number of days subjects smoked no cigarettes during the intervention was compared between groups.	8 weeks (56 (+/-5) days)
Secondary	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
Secondary	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
Secondary	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