Contingency Management for Smoking Cessation in the Homeless

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Connecticut Health Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01736982
First received: November 26, 2012
Last updated: February 24, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention
Cigarette Smoking
Behavioral: Contingency Management
Behavioral: Standard smoking cessation counseling
Drug: transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)],
Behavioral: Breath sample monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Contingency Management for Smoking Cessation in the Homeless

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Longest Duration of Abstinence [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care
transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)], breath sample monitoring, standard smoking cessation counseling.
Behavioral: Standard smoking cessation counseling Drug: transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)], Behavioral: Breath sample monitoring
Experimental: Standard Care plus Contingency Management
Standard smoking cessation intervention plus contingency management
Behavioral: Contingency Management
Participants earn reinforcement in the form of prizes for breath samples that test negative for cigarette smoking.
Behavioral: Standard smoking cessation counseling Drug: transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)], Behavioral: Breath sample monitoring

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • homeless
  • regular smoker

Exclusion Criteria:

  • non-English speaking
  • contra-indications for transdermal nicotine
  • in recovery for pathological gambling
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736982

Contacts
Contact: Ellen M Ciesielski 860.679.4556 eciesielski@uchc.edu

Locations
United States, Connecticut
The Friendship Center Recruiting
New Britain, Connecticut, United States, 06051
Principal Investigator: Carla Rash, Ph.D.         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Carla J Rash, PhD University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01736982     History of Changes
Other Study ID Numbers: 12-186-2, R21DA031897
Study First Received: November 26, 2012
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Cigarette Smoking
Homeless
Contingency Management
Smoking Cessation

ClinicalTrials.gov processed this record on October 20, 2014