Methods Project 4: Clinical Trial - Amended

NCT ID: NCT03111537

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2018-02-28

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.

Conditions

Tobacco Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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);

Group Type: EXPERIMENTAL

Cigarettes

Intervention Type: OTHER

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

Complete Substitution E-Cigarette

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

Group Type: EXPERIMENTAL

E-Cigarette

Intervention Type: OTHER

Use of E-cigarette: multiple flavors offered.

Partial Substitution E-Cigarette

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

Group Type: EXPERIMENTAL

Cigarettes

Intervention Type: OTHER

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

E-Cigarette

Intervention Type: OTHER

Use of E-cigarette: multiple flavors offered.

Complete Substitution Nic Gum or Lozenge

Complete substitution (i.e., no smoking) to nicotine gum or lozenge use

Group Type: EXPERIMENTAL

Nicotine Gum or Lozenge

Intervention Type: OTHER

Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered

Interventions

Cigarettes

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

Intervention Type: OTHER

E-Cigarette

Use of E-cigarette: multiple flavors offered.

Intervention Type: OTHER

Nicotine Gum or Lozenge

Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Roswell Park Cancer Center

Buffalo, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2012NTLS050b

Identifier Type: -

Identifier Source: org_study_id