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Methods Project 4: Clinical Trial - Amended

NCT03111537 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2022-09-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03111537 on ClinicalTrials.gov