Methods Project 4: Clinical Trial

NCT01867242 | Completed Results

• 2 other identifiers: 2012NTLS0505U19CA157345
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

Smoker

Keywords

cigarette; snus; smoking; tobacco

Outcome Measures

Primary Outcomes (1)

• Smoke-free Days

  Number of days subjects smoked no cigarettes during the intervention was compared between groups.

  8 weeks (56 (+/-5) days)

Secondary Outcomes (3)

• CEMA (2-cyanoethylmercapturic Acid)

  8 weeks

• Total Nicotine Exposure

  8 weeks

• Urinary Total NNAL

  8 weeks

Study Arms (3)

Usual Brand Cigarette

EXPERIMENTAL

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);

Other: Cigarettes

Complete Substitution

EXPERIMENTAL

Use snus in place of cigarettes

Other: Snus

Partial Substitution (Snus and Cigarettes)

EXPERIMENTAL

Use snus and cigarettes how ever you like

Other: Cigarettes; Other: Snus

Interventions

Cigarettes OTHER

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

Partial Substitution (Snus and Cigarettes); Usual Brand Cigarette

Snus OTHER

Winterchill or Robust flavors

Also known as: Camel Snus

Complete Substitution; Partial Substitution (Snus and Cigarettes)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Roswell Park Cancer Center

Buffalo, New York, 14263, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Tobacco Products; Tobacco, Smokeless

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dorothy Hatsukami, PhD
• Organization: University of Minnesota

hatsu001@umn.edu

612-626-2121

Study Officials

• Dorothy Hatsukami, M.D.

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 3, 2023
• Results First Posted: April 25, 2023

Record last verified: 2023-04

Locations

US (3)