CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 235 enrolled
Drug / intervention
Nicotine Patch +2 moredrug
Likely dose
Nicotine Patch 21 mgfrom 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/NCT01050569
NCT01050569Phase 2Completed
CompareCT.gov

Innovative Interventions for Smoking Cessation: Comparison of Very Low Nicotine Content Cigarettes Plus Nicotine Patch; Very Low Nicotine Content Cigarettes Alone or Nicotine Patch Alone

University of Minnesota·interventional·Posted Jan 15, 2010·Updated Nov 18, 2019

In Brief

A Phase 2 clinical trial evaluating Nicotine Patch, VLNC Cigarette, and 1 other intervention for Tobacco Use Disorder. Completed, enrolled 235 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2010
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2011
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 16.5 years ago

Interventions

Nicotine Patchdrug

21 mg

VLNC Cigaretteother

Cigarette where the tobacco contains \<0.1 mg of nicotine yield.

VLNC Cigarette Plus Nicotine Patchother

21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.