Contingency Management for Smoking Cessation in Homeless Smokers

This study has suspended participant recruitment.
(Initial pilot period of project has completed. The project is currently unfunded, but enrollment will resume if funding is awarded.)
Sponsor:
Collaborator:
Durham VA Medical Center
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01789710
First received: February 8, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Smoking
Homeless Persons
Drug: Bupropion
Drug: Nicotine replacement therapy
Behavioral: Contingency Management

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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Breath carbon monoxide [ Time Frame: Throughout study - one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Saliva cotinine [ Time Frame: 2 months, 3 months, 6 months ] [ Designated as safety issue: No ]
    When the body processes nicotine, it produces cotinine. Cotinine can be found in saliva.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01789710

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01789710     History of Changes
Other Study ID Numbers: Pro00040194
Study First Received: February 8, 2013
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
smoking
homelessness
contingency management

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014