NCT00828113

Brief Summary

This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2009

Typical duration for phase_4

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

January 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 18, 2012

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

January 21, 2009

Results QC Date

June 13, 2012

Last Update Submit

October 22, 2015

Conditions

Smoking

Keywords

smokingrelapsewithdrawal

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52

    Self-report of no smoking (not even a puff) in the previous seven days confirmed by an expired carbon monoxide reading of \< 10 parts per million as assessed at Week 52

    7-day point prevalence

Study Arms (2)

Extended treatment

EXPERIMENTAL

52-week varenicline therapy + individual smoking cessation counseling

Drug: vareniclineBehavioral: Individual smoking cessation counseling

Standard treatment

ACTIVE COMPARATOR

13 weeks of varenicline therapy + individual smoking cessation counseling

Drug: vareniclineBehavioral: Individual smoking cessation counseling

Interventions

vareniclineDRUG

Extension of 1 mg twice daily treatment to 52 weeks

Extended treatmentStandard treatment
Individual smoking cessation counselingBEHAVIORAL

Brief (\<10 minutes) smoking cessation counseling delivered at clinic visits

Extended treatmentStandard treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • daily smoker
  • + cigarettes per day for at least one year
  • expired carbon monoxide level of 5+ ppm

You may not qualify if:

  • current use of smoking cessation pharmacotherapies
  • current or history of psychotic disorder
  • current major depressive disorder
  • history of suicidal ideation in the previous 3 months
  • unstable medical condition
  • pregnant, nursing, or planning to become pregnant
  • planning to move from study area within 18 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

Center for Tobacco Research and Intervention

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (1)

  • 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

SmokingRecurrence

Interventions

Varenicline

Condition Hierarchy (Ancestors)

BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Feasibility study with limited statistical power at baseline compounded by a significant rate of attrition during the study.

Results Point of Contact

Title
Douglas E. Jorenby, Ph.D.
Organization
University of Wisconsin School of Medicine and Public Health
dej@ctri.medicine.wisc.edu
6082627527

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 23, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2010

Study Completion

February 1, 2011

Last Updated

November 20, 2015

Results First Posted

July 18, 2012

Record last verified: 2015-10

Locations

US(2)