CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 74 enrolled
Drug / intervention
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03060083
NCT03060083Phase 3Completed

A Randomized Trial to Compare Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day

University of Vermont·interventional·Posted Feb 23, 2017·Updated Oct 4, 2022

In Brief

A Phase 3 clinical trial evaluating Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT) and Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT) for Tobacco Use Disorder. Completed, enrolled 74 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartFeb 8, 2017
Primary CompletionNov 16, 2017
Study CompletionJan 10, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.4 years ago

Interventions

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

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

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

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