NCT01736982

Brief Summary

Smoking cessation services are an unmet need among the homeless, who smoke at rates more than 3 times the national estimate; successful interventions in this underserved population have the potential for improving individual and public health. Contingency management (CM) is a behavioral intervention with efficacy in a number of substance use disorder populations, including smokers. However, no known studies have evaluated the effect of CM in homeless smokers. The investigators plan to examine smoking-related outcomes in homeless treatment-seeking smokers (N = 70) randomized to standard care smoking cessation (transdermal nicotine replacement therapy \[NRT\] + standard counseling + carbon monoxide \[CO\] monitoring) or standard care plus CM (NRT + standard counseling + CO monitoring + CM) conditions. Standard counseling and CO monitoring will occur for the first 4 weeks, with NRT use continuing through week 8. Participants in both conditions will meet with study staff up to twice daily on weekdays for biochemical verification of smoking status. Participants in the CM condition will have the opportunity to earn prizes for negative breath samples (CO ≤ 4 ppm) up to twice daily on weekdays. CO breath samples will be collected at all visits. The investigators expect that participants randomized to CM will have better outcomes compared to those in standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

November 26, 2012

Last Update Submit

January 11, 2018

Conditions

Keywords

Cigarette SmokingHomelessContingency ManagementSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Longest Duration of Abstinence

    Week 4

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

transdermal nicotine replacement \[21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)\], breath sample monitoring, standard smoking cessation counseling

Other: Standard of Care

Standard of Care plus Contingency Management

EXPERIMENTAL

Standard smoking cessation intervention plus contingency management

Behavioral: Contingency ManagementOther: Standard of Care

Interventions

Participants earn reinforcement in the form of prizes for breath samples that test negative for cigarette smoking.

Standard of Care plus Contingency Management

Standard smoking cessation counseling

Standard of CareStandard of Care plus Contingency Management

Eligibility Criteria

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

You may qualify if:

  • age ≥ 18 years
  • homeless
  • regular smoker

You may not qualify if:

  • non-English speaking
  • contra-indications for transdermal nicotine
  • in recovery for pathological gambling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Friendship Center

New Britain, Connecticut, 06051, United States

Location

MeSH Terms

Conditions

Cigarette SmokingSmoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseHealth Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Carla J Rash, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 29, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations