NCT03111537

Methods Project 4: Clinical Trial - Amended

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
OTHER	Nicotine Gum or Lozenge	Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2017-04-13
• Last updated: 2022-09-28

Locations

3 sites across 1 country: United States