Contingency Management for Smoking Cessation in Homeless Smokers

June 10, 2015 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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:
  • Nicotine lozenge
  • Nicoderm CQ, Nicotine patch
  • Nicotine polacrilex, nicotine gum
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breath carbon monoxide
Time Frame: Throughout study - one year
Throughout study - one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saliva cotinine
Time Frame: 2 months, 3 months, 6 months
When the body processes nicotine, it produces cotinine. Cotinine can be found in saliva.
2 months, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Durham VA Medical Center

Investigators

  • Principal Investigator: Jean C. Beckham, Ph.D., Duke University Medical Center; VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (ESTIMATE)

February 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00040194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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