NCT00786149

Brief Summary

the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
428

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

September 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 3, 2014

Status Verified

September 1, 2014

Enrollment Period

3.5 years

First QC Date

November 5, 2008

Last Update Submit

September 2, 2014

Conditions

Tobacco Use Cessation

Keywords

Underserved populationsHomelessnessNicotine replacement therapyCounselingCancer Prevention and control

Outcome Measures

Primary Outcomes (1)

  • 7-day point prevalence abstinence from smoking

    6 months after enrollment

Secondary Outcomes (2)

  • Adherence to treatment

    12 weeks and 6 months after enrollment

  • Moderating effects of psychiatric co-morbidities and other substance abuse on treatment

    6 months after enrollment

Study Arms (2)

1

EXPERIMENTAL

Participants will receive NRT and Motivational Interviewing counseling

Other: Varenicline plus Motivational Interviewing counseling

2

ACTIVE COMPARATOR

Varenicline plus brief advice

Other: Varenicline without counseling

Interventions

Varenicline plus Motivational Interviewing counselingOTHER

Motivational Interviewing; 8 weeks of counseling

Also known as: Chantix
1
Varenicline without counselingOTHER

Brief advice, one time during initial session

Also known as: Chantix
2

Eligibility Criteria

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

You may qualify if:

  • currently homeless
  • smoke 5 or more cigarettes per day
  • smoked 100 cigarettes in lifetime
  • aged 18 years or older

You may not qualify if:

  • unstable mental illness
  • pregnancy
  • current history of psychoactive or alcohol dependence or psychotic disorder
  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (4)

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • Ojo-Fati O, Joseph AM, Ig-Izevbekhai J, Thomas JL, Everson-Rose SA, Pratt R, Raymond N, Cooney NL, Luo X, Okuyemi KS. Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned. Trials. 2017 Jul 5;18(1):305. doi: 10.1186/s13063-017-2046-9.

    PMID: 28679430DERIVED

  • Ojo-Fati O, Thomas JL, Vogel RI, Ogedegbe O, Jean-Louis G, Okuyemi KS. Predictors of Adherence to Nicotine Replacement Therapy (Nicotine Patch) Among Homeless Persons Enrolled in a Randomized Controlled Trial Targeting Smoking Cessation. J Fam Med. 2016;3(7):1079. Epub 2016 Sep 6.

    PMID: 28580456DERIVED

  • Goldade K, Whembolua GL, Thomas J, Eischen S, Guo H, Connett J, Des Jarlais D, Resnicow K, Gelberg L, Owen G, Grant J, Ahluwalia JS, Okuyemi KS. Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial. Clin Trials. 2011 Dec;8(6):744-54. doi: 10.1177/1740774511423947.

    PMID: 22167112DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

VareniclineCounseling

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalinesMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kolawole S Okuyemi, MD,MPH

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 3, 2014

Record last verified: 2014-09

Locations

US(1)