Methods Project 4: Clinical Trial - Amended

NCT03111537 | Completed

• 1 other identifier: 2012NTLS050b
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 3

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.

Conditions

Tobacco Smoking

Keywords

cigarette; smoking; e-cigarette; nicotine replacement therapy; nrt; tobacco

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Usual Brand Cigarette

EXPERIMENTAL

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

Complete Substitution E-Cigarette

EXPERIMENTAL

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

Other: E-Cigarette

Partial Substitution E-Cigarette

EXPERIMENTAL

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

Other: Cigarettes; Other: E-Cigarette

Complete Substitution Nic Gum or Lozenge

EXPERIMENTAL

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

Other: Nicotine Gum or Lozenge

Interventions

Cigarettes OTHER

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

Partial Substitution E-Cigarette; Usual Brand Cigarette

E-Cigarette OTHER

Use of E-cigarette: multiple flavors offered.

Complete Substitution E-Cigarette; Partial Substitution E-Cigarette

Nicotine Gum or Lozenge OTHER

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

Complete Substitution Nic Gum or Lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• Unstable health;
• Pregnant or breastfeeding (due to toxic effects from tobacco products);
• Unable to read for comprehension or completion of study documents.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (3)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Roswell Park Cancer Center

Buffalo, New York, 14263, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Tobacco Smoking; Smoking; Vaping

Interventions

Tobacco Products; Electronic Nicotine Delivery Systems; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: April 13, 2017
• Study Start: May 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (3)