Methods Project 4: Clinical Trial

NCT ID: NCT01867242

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-05-31

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.

Conditions

Smoker

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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);

Group Type: EXPERIMENTAL

Cigarettes

Intervention Type: OTHER

Smoke their usual brand of cigarettes and follow their normal patterns of use.

Complete Substitution

Use snus in place of cigarettes

Group Type: EXPERIMENTAL

Snus

Intervention Type: OTHER

Winterchill or Robust flavors

Partial Substitution (Snus and Cigarettes)

Use snus and cigarettes how ever you like

Group Type: EXPERIMENTAL

Cigarettes

Intervention Type: OTHER

Smoke their usual brand of cigarettes and follow their normal patterns of use.

Snus

Intervention Type: OTHER

Winterchill or Robust flavors

Interventions

Cigarettes

Smoke their usual brand of cigarettes and follow their normal patterns of use.

Intervention Type: OTHER

Snus

Winterchill or Robust flavors

Intervention Type: OTHER

Other Intervention Names

Camel Snus

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothy Hatsukami, M.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Roswell Park Cancer Center

Buffalo, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5U19CA157345

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012NTLS050

Identifier Type: -

Identifier Source: org_study_id