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Contingency Management for Smoking Cessation in the Homeless

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ClinicalTrials.gov Identifier: NCT01736982
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contingency Management for Smoking Cessation in the Homeless
Study Start Date : October 2012
Primary Completion Date : July 2016
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Longest Duration of Abstinence [ Time Frame: Week 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736982


Locations
United States, Connecticut
The Friendship Center
New Britain, Connecticut, United States, 06051
Sponsors and Collaborators
UConn Health
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Carla J Rash, PhD UConn Health
More Information

Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT01736982     History of Changes
Other Study ID Numbers: 12-186-2
R21DA031897 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UConn Health:
Cigarette Smoking
Homeless
Contingency Management
Smoking Cessation

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action