Methods Project 4: Clinical Trial - Amended

Tobacco Smoking Clinical Trial

— COMET  

Official title:

Project 4: Clinical Trial Method for Assessing a Tobacco Product Part of Models for Tobacco Product Evaluation:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111537
• Other study ID #: 2012NTLS050b
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: February 2018

Study information

• Verified date: September 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cigarette smokers will be randomized to E-cigarette, Nicotine Gum or Lozenge, or Control Group. Participants will enter a 1 week sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then enter an 8 week intervention. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.

Description:

Sampling period (1 week): Subjects will be randomized to an alternative nicotine product (E-cigarette, Nicotine Gum or Lozenge) or assigned to continue smoking their usual brand cigarettes. Subjects will complete screening assessments, asked to sample the assigned product and start recording their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR). Smokers assigned to the control condition (smoking usual brand cigarettes) will be asked to choose the product that they would like to sample.

Baseline smoking period: After sampling, subjects who meet specific criteria will continue with the experimental intervention phase. These subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured. Records of their cigarette or other tobacco intake on a daily basis will continue using the interactive voice response system (IVR).

Experimental Period: After the baseline assessment, subjects will be instructed to either partially or completely substitute their cigarette smoking with their assigned product. They will assigned to one of six experimental conditions:

1. smoking usual brand cigarette controls, who after 8-weeks will be offered any of the other nicotine products to use as they choose for 8 weeks;

2. complete substitution (i.e., no smoking) with an E-cigarette;

3. partial substitution with an E-cigarette;

4. complete substitution (i.e., no smoking) with nicotine gum or nicotine lozenge.

The assigned product, E-cigarette, Nic Gum or Lozenge, but not usual brand 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: 264
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• 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

• Tobacco Smoking

Intervention

Other:
• Cigarettes
Smoke their usual brand of cigarettes and follow their normal patterns of use.
• E-Cigarette
Use of E-cigarette: multiple flavors offered.
• Nicotine Gum or Lozenge
Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered

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 (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare total nicotine equivalents (TNE) based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.	Compare the exposure to nicotine in the two instructions for use arms (complete substitution vs. partial substitution) across study products and compared to medicinal nicotine products and usual brand cigarettes.	6 months
Primary	Determine stabilization of product use (e.g., cigarette, oral tobacco, e-cigarette or medicinal nicotine patterns of use).	Examining time effects for patterns of use of cigarettes, nicotine replacement, oral tobacco or e-cigarette.	6 months
Primary	Consumer perception of the product and response to the product after sampling.	Consumer perception of the product evidenced by choice of which product to use in the trial after sampling.	6 months
Primary	Compare NNK exposure based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.	Complete substitution vs. partial substitution of study products for cigarettes and compare the exposure to NNK by analyzing NNAL levels in subject urine. These products are compared to medicinal nicotine products and usual brand cigarettes.	8 weeks