Methods Project 4: Clinical Trial

University of Minnesota (UMN)

Status: Completed

Conditions: Smoker

Treatments: Other: Snus; Other: Cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01867242

5U19CA157345 (U.S. NIH Grant/Contract)

2012NTLS050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

150 participants in 3 patient groups

Usual Brand Cigarette

Experimental group

Description:

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);

Treatment:

Other: Cigarettes

Complete Substitution

Experimental group

Description:

Use snus in place of cigarettes

Treatment:

Other: Snus

Partial Substitution (Snus and Cigarettes)

Experimental group

Description:

Use snus and cigarettes how ever you like

Treatment:

Other: Snus

Other: Cigarettes