Contingency Management for Smoking Cessation in Homeless Smokers

NCT ID: NCT01789710

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-09-30

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.

Conditions

Smoking; Homeless Persons

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupropion

Intervention Type: DRUG

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

Nicotine replacement therapy

Intervention Type: DRUG

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

Contingency Management

Intervention Type: BEHAVIORAL

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).

Interventions

Bupropion

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

Intervention Type: DRUG

Nicotine replacement therapy

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

Intervention Type: DRUG

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Zyban; Nicoderm CQ, Nicotine patch; Nicotine polacrilex, nicotine gum; Nicotine lozenge

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Durham VA Medical Center

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean C. Beckham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center; VA Medical Center

Locations

VA Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25699616 (View on PubMed)

Other Identifiers

Pro00040194

Identifier Type: -

Identifier Source: org_study_id