Contingency Management for Smoking Cessation in Homeless Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01789710
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : June 12, 2015
Durham VA Medical Center
Information provided by (Responsible Party):
Duke University

Brief Summary:

The purpose of this study is to examine the effectiveness of an internet-based contingency management program for smoking cessation in persons who are homeless. Thirty homeless smokers will be enrolled in the study. Participants will receive payment based on their own low carbon monoxide readings, which indicate being quit from smoking. Participants will be prescribed nicotine replacement (patches and either gum or lozenge)and bupropion. All participants will receive a four sessions of smoking cessation counseling, and will be trained to perform carbon monoxide monitoring with a device provided by the study. They will also be provided with a mobile phone equipped with a video camera, and will use this equipment at home to monitor their carbon monoxide . Participants will record videos of themselves taking a carbon monoxide reading and displaying the results, and will upload the videos to a secured website that is only accessible by the research team members and the participant. Payment will be based on providing carbon monoxide readings that indicate abstinence.

The study is designed to address the following aims:

Specific Aim 1: To evaluate whether it is feasible to use internet-based contingency management for helping smokers who are homeless stop smoking.

Specific Aim 2: To evaluate how effective internet-based contingency managementis on decreasing smoking in smokers who are homeless.

Condition or disease Intervention/treatment Phase
Smoking Homeless Persons Drug: Bupropion Drug: Nicotine replacement therapy Behavioral: Contingency Management Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contingency Management for Smoking Cessation in Homeless Smokers
Study Start Date : January 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Contingency Management
All participants are assigned to a single arm, active contingency management. In this arm, participants are provided monetary rewards for remaining abstinent from smoking.
Drug: Bupropion
All participants who are medically eligible to take Bupropion will receive this study medication one week prior to their smoking quit date.
Other Name: Zyban

Drug: Nicotine replacement therapy
All participants will receive two forms of nicotine replacement therapy - nicotine patches and a rescue method (either gum or lozenge).
Other Names:
  • Nicoderm CQ, Nicotine patch
  • Nicotine polacrilex, nicotine gum
  • Nicotine lozenge

Behavioral: Contingency Management
All participants will be asked to provide home carbon monoxide monitoring with equipment that is loaned to them. When participants provide readings that are low enough to suggest abstinence from smoking, they are provided monetary reinforcement (i.e., money).

Primary Outcome Measures :
  1. Breath carbon monoxide [ Time Frame: Throughout study - one year ]

Secondary Outcome Measures :
  1. Saliva cotinine [ Time Frame: 2 months, 3 months, 6 months ]
    When the body processes nicotine, it produces cotinine. Cotinine can be found in saliva.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • must be a Veteran who is eligible for care within the VA system;
  • must be currently homeless or have been homeless more than twice in the past year period;
  • must have current smoking status of at least 10 cigarettes per day for at least 1 year (verified with breath carbon monoxidemeasurement);
  • must be aged 18 to 70;
  • must be English speaker

Exclusion Criteria:

  • Pregnancy;
  • Any substance use disorder in any of the following drug categories: opioids, cocaine, alcohol, sedatives, stimulants, hallucinogens, or drugs categorized as "other" per the Structured Clinical Interview for Diagnostic and Statistical Manual-IV.
  • Urine drug screen results positive for cocaine, amphetamines, stimulants, opioids, or hallucinogens;
  • Not stable on medications for the study period;
  • Use of any other forms of nicotine such as cigars, pipes, or chewing tobacco;
  • Participants may be excluded if they have a seizure disorder, uncontrolled diabetes or an eating disorder;
  • Prior history of hepatitis or cirrhosis; current hepatitis or cirrhosis
  • Score less than 80 on Kaufman Brief Intelligence Test

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 identifier (NCT number): NCT01789710

United States, North Carolina
VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Durham VA Medical Center
Principal Investigator: Jean C. Beckham, Ph.D. Duke University Medical Center; VA Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT01789710     History of Changes
Other Study ID Numbers: Pro00040194
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Keywords provided by Duke University:
contingency management

Additional relevant MeSH terms:
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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors