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Innovative Interventions for Smoking Cessation

NCT01050569 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2019-11-18

Study results available
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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.

Conditions

  • Tobacco Use Disorder

Interventions

DRUG

Nicotine Patch

21 mg

OTHER

VLNC Cigarette

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

OTHER

VLNC Cigarette Plus Nicotine Patch

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

Sponsors & Collaborators

Principal Investigators

  • Dorothy Hatsukami, PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-12-31
Completion
2012-06-30

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 NCT01050569 on ClinicalTrials.gov