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Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day

NCT03060083 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-10-04

Study results available
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Summary

The FDA recently gained the authority to regulate the nicotine content of cigarettes. Prior research suggests that smokers who switch to very low nicotine content (VLNC) cigarettes experience reduced addiction to nicotine and are more likely to quit smoking. Currently, the most common method for smokers to reduce their nicotine intake is to reduce their number of cigarettes per day (CPD). No research has compared reducing smokers' nicotine intake by switching to VLNC cigarettes vs by reducing CPD with regard to decreasing dependence or quitting; thus the investigators will examine the two strategies by randomizing smokers to 1) switch to VLNC cigarettes or 2) reduce CPD. In addition, all smokers will use the nicotine patch to help them reduce their nicotine intake.

Conditions

  • Tobacco Use Disorder

Interventions

OTHER

Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT)

Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)

OTHER

Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT)

Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)

Sponsors & Collaborators

  • University of Vermont

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2017-11-16
Completion
2018-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03060083 on ClinicalTrials.gov