Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Methods Project 4: Clinical Trial

Protocol: OSU-14104

Full Title

Clinical Trial Methods For Assessing A Tobacco Product

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.

Study Objective

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.

Are you eligible?

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.