Methods Project 4: Clinical Trial - Amended (COMET)

University of Minnesota (UMN)

Status

Completed

Conditions

Tobacco Smoking

Treatments

Other: Cigarettes

Other: Nicotine Gum or Lozenge

Other: E-Cigarette

Study type

Interventional

Funder types

Other

Identifiers

NCT03111537

2012NTLS050b

Details and patient eligibility

About

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.

Full 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:

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

Enrollment

264 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

Parallel Assignment

Masking

None (Open label)

264 participants in 4 patient groups

Usual Brand Cigarette

Experimental group

Description:

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);

Treatment:

Other: Cigarettes

Complete Substitution E-Cigarette

Experimental group

Description:

Complete substitution (i.e., no smoking) with e-cigarette use

Treatment:

Other: E-Cigarette

Partial Substitution E-Cigarette

Experimental group

Description:

Partial substitution, encouraged to use e-cigarettes instead of smoking usual cigarettes