CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 775 enrolled
Drug / intervention
Very low nicotine content cigarettesother
Likely dose
Not stated in record
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Search/NCT02250664
NCT02250664Phase 2Completed

Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers

University of Vermont·interventional·Posted Sep 26, 2014·Updated Dec 1, 2022

In Brief

A Phase 2 clinical trial evaluating Very low nicotine content cigarettes for Tobacco Use Disorder. Completed, enrolled 775 participants across 2 sites.

Detailed Summary

This study will examine extended exposure to cigarettes varying in nicotine content among adults with opioid use disorder. Those with opioid use disorder are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including site specific cancers, heart disease, and premature death. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like those with opioid use disorder who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 26, 2014
Enrollment StartOct 1, 2016
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 11.8 years ago

Interventions

Very low nicotine content cigarettesother

Very low nicotine content cigarettes