Clinical trial NCT03111537: Methods Project 4: Clinical Trial - Amended
Official title: Project 4: Clinical Trial Method for Assessing a Tobacco Product Part of Models for Tobacco Product Evaluation:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Keywords: cigarette
smoking
e-cigarette
nicotine replacement therapy
nrt
tobacco
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

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.

Primary outcomes:
measure: Compare total nicotine equivalents (TNE) based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
timeFrame: 6 months
measure: Determine stabilization of product use (e.g., cigarette, oral tobacco, e-cigarette or medicinal nicotine patterns of use).
timeFrame: 6 months
measure: Consumer perception of the product and response to the product after sampling.
timeFrame: 6 months
measure: Compare NNK exposure based on differing instructions for oral tobacco, nicotine replacement or e-cigarette use.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Cancer Center
state: New York
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
References: