NCT00595868

Brief Summary

The purpose of this study is to test whether Varenicline can help ambivalent smokers (those who are interested in quitting at some point in the future but have no current plans to quit) to reduce their smoking and eventually quit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2008

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

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 22, 2011

Completed
Last Updated

December 2, 2011

Status Verified

November 1, 2011

Enrollment Period

1.8 years

First QC Date

January 4, 2008

Results QC Date

September 7, 2011

Last Update Submit

November 22, 2011

Conditions

Tobacco Use DisorderTobacco Use CessationNicotine Dependence

Keywords

NicotineSmokingSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With a Quit Attempt

    A quit attempt was defined as a self-reported attempt to quit smoking on a given day reported on a Time Line Follow Back (TLFB) obtained at each visit for the first 2 months and via monthly phone calls during months 3-6. The TLFB collected information for each day since the previous visit/call on number of cigarettes smoked that day, whether medication (varenicline or placebo) was used that day, and whether a quit attempt occured that day.

    6 months

Secondary Outcomes (1)

  • 7 Day Point Prevalent Abstinence Verified by Breath Carbon Monoxide of Less Than 10 Parts Per Million

    6 months

Study Arms (2)

Varenicline

EXPERIMENTAL
Drug: Varenicline

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

VareniclineDRUG

0.5 milligrams two times per day for 3 days, then 1.0 milligrams two times per day for an addition 11 days - 2 months

Also known as: Chantix
Varenicline
PlaceboDRUG

same as Varenicline arm

Placebo

Eligibility Criteria

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

You may qualify if:

  • At least 18 years old
  • Able to get to research lab in Burlington, Vermont or Omaha, Nebraska
  • Daily smoker
  • Smoke at least 8 cigarettes per day
  • No reduction in smoking in last 30 days
  • No intention to quit in the next 30 days
  • Never used Varenicline before
  • Not currently using smoking cessation medications or nicotine replacement therapy
  • Willing to use Varenicline for at least 2 weeks
  • Fluent in English

You may not qualify if:

  • Cannot be currently pregnant or breastfeeding
  • Kidney disease
  • Frequent nausea
  • On certain medications for asthma and/or depression
  • Another household member in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

  • Hughes JR, Rennard SI, Fingar JR, Talbot SK, Callas PW, Fagerstrom KO. Efficacy of varenicline to prompt quit attempts in smokers not currently trying to quit: a randomized placebo-controlled trial. Nicotine Tob Res. 2011 Oct;13(10):955-64. doi: 10.1093/ntr/ntr103. Epub 2011 Jun 7.

    PMID: 21652735RESULT

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use CessationSmokingSmoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Results Point of Contact

Title
John R. Hughes, MD
Organization
University of Vermont
john.hughes@uvm.edu
802-656-3195

Study Officials

  • John R Hughes, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 2, 2011

Results First Posted

November 22, 2011

Record last verified: 2011-11

Locations

US(2)