NCT01050569

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 28, 2014

Completed
Last Updated

November 18, 2019

Status Verified

October 1, 2019

Enrollment Period

3.2 years

First QC Date

January 14, 2010

Results QC Date

October 29, 2013

Last Update Submit

October 30, 2019

Conditions

Tobacco Use Disorder

Keywords

Smoking CessationNicotine Free Cigarettes

Outcome Measures

Primary Outcomes (2)

  • End of Treatment Abstinence Rate

    Cotinine and carbon monoxide (CO) verified point prevalence abstinence

    12 week

  • End of Follow-up Abstinence Rates

    CO- and cotinine-verified point prevalence abstinence

    36 weeks

Secondary Outcomes (2)

  • Exposure to Tobacco Toxicants

    6 weeks

  • Time to Lapse or Relapse to Tobacco Use

    26 weeks

Study Arms (3)

VLNC Cigarette

ACTIVE COMPARATOR

Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks.

Other: VLNC Cigarette

Nicotine Patch

ACTIVE COMPARATOR

21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks.

Drug: Nicotine Patch

VLNC Cigarette plus Nicotine Patch

EXPERIMENTAL

Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks

Other: VLNC Cigarette Plus Nicotine Patch

Interventions

Nicotine PatchDRUG

21 mg

Also known as: Nicoderm CQ
Nicotine Patch
VLNC CigaretteOTHER

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

Also known as: Quest 3, Xodus
VLNC Cigarette
VLNC Cigarette Plus Nicotine PatchOTHER

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

Also known as: Nicoderm CQ, Quest 3, Xodus
VLNC Cigarette plus Nicotine Patch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a) Smoking at least 10 cigarettes daily for the past year;
  • b) In good physical health;
  • c) No contraindications for medicinal nicotine; and
  • d) Stable, good mental health.

You may not qualify if:

  • a) Subjects must not be using other tobacco or nicotine products.
  • b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Minnesota

Duluth, Minnesota, 55812, United States

Location

University of MN's Tobacco Use Research Center

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (2)

  • Hatsukami DK, Hertsgaard LA, Vogel RI, Jensen JA, Murphy SE, Hecht SS, Carmella SG, al'Absi M, Joseph AM, Allen SS. Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1015-24. doi: 10.1158/1055-9965.EPI-12-1439. Epub 2013 Apr 19.

    PMID: 23603206RESULT

  • Dermody SS, Donny EC, Hertsgaard LA, Hatsukami DK. Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob Control. 2015 Nov;24(6):536-9. doi: 10.1136/tobaccocontrol-2014-051797. Epub 2014 Sep 5.

    PMID: 25192771DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Interventions

Tobacco Use Cessation DevicesNicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Limitations and Caveats

Small sample size.

Results Point of Contact

Title
Dorothy Hatsukami
Organization
University of Minnesota
hatsu001@umn.edu
612 626-2121

Study Officials

  • Dorothy Hatsukami, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

October 1, 2008

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

November 18, 2019

Results First Posted

February 28, 2014

Record last verified: 2019-10

Locations

US(2)