NCT01789710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 4, 2026

Status Verified

June 1, 2015

Enrollment Period

1.7 years

First QC Date

February 8, 2013

Last Update Submit

April 28, 2026

Conditions

Keywords

smokinghomelessnesscontingency management

Outcome Measures

Primary Outcomes (1)

  • Breath carbon monoxide

    Throughout study - one year

Secondary Outcomes (1)

  • Saliva cotinine

    2 months, 3 months, 6 months

Study Arms (1)

Active Contingency Management

EXPERIMENTAL

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: BupropionDrug: Nicotine replacement therapyBehavioral: Contingency Management

Interventions

All participants who are medically eligible to take Bupropion will receive this study medication one week prior to their smoking quit date.

Also known as: Zyban
Active Contingency Management

All participants will receive two forms of nicotine replacement therapy - nicotine patches and a rescue method (either gum or lozenge).

Also known as: Nicoderm CQ, Nicotine patch, Nicotine polacrilex, nicotine gum, Nicotine lozenge
Active 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).

Active Contingency Management

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Carpenter VL, Hertzberg JS, Kirby AC, Calhoun PS, Moore SD, Dennis MF, Dennis PA, Dedert EA, Hair LP, Beckham JC. Multicomponent smoking cessation treatment including mobile contingency management in homeless veterans. J Clin Psychiatry. 2015 Jul;76(7):959-64. doi: 10.4088/JCP.14m09053.

MeSH Terms

Conditions

Smoking

Interventions

BupropionNicotine Replacement TherapyNicotineTobacco Use Cessation DevicesNicotine Chewing Gum

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsDrug TherapyTherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingChewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jean C. Beckham, Ph.D.

    Duke University Medical Center; VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 12, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 4, 2026

Record last verified: 2015-06

Locations