Methods Project 4: Clinical Trial - Amended (COMET)

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking
• Intervention / Treatment: Other: Cigarettes; Other: E-Cigarette; Other: Nicotine Gum or Lozenge

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual Brand Cigarette; Smoking usual brand cigarette controls, who after 8-weeks will be offered alternative nicotine products and instructed for partial or complete substitution of cigarettes (subject's choice);	Other: Cigarettes; Smoke their usual brand of cigarettes and follow their normal patterns of use.
Experimental: Complete Substitution E-Cigarette; Complete substitution (i.e., no smoking) with e-cigarette use	Other: E-Cigarette; Use of E-cigarette: multiple flavors offered.
Experimental: Partial Substitution E-Cigarette; Partial substitution, encouraged to use e-cigarettes instead of smoking usual cigarettes	Other: Cigarettes; Smoke their usual brand of cigarettes and follow their normal patterns of use.; Other: E-Cigarette; Use of E-cigarette: multiple flavors offered.
Experimental: Complete Substitution Nic Gum or Lozenge; Complete substitution (i.e., no smoking) to nicotine gum or lozenge use	Other: Nicotine Gum or Lozenge; Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: smoking; tobacco; nicotine replacement therapy; e-cigarette; cigarette; nrt
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2012NTLS050b