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Durham, North Carolina 27705


Purpose:

The goal of this research study is to examine the effects of a treatment for helping homeless veterans who smoke to stop smoking. Participants in the study will be assigned to one of two study groups. Participants in the first group will be referred to the local Department of Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group participants will receive a behavioral treatment designed to reward smokers for quitting and staying quit. These participants will also receive telephone counseling and medications for smoking cessation.


Study summary:

Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and mortality. Veterans who are homeless, along with those who have mental health or substance abuse problems, are at the highest risk for nicotine dependence. Prevalence estimates for smoking among homeless Veterans are 80%. Thus, homeless Veterans are at tremendous risk for smoking related morbidity and mortality. This information suggests that smoking needs to be targeted specifically among this high risk population of smokers. The addition of contingency management (CM) to existing evidence-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is a behavioral therapy that provides positive reinforcers to individuals misusing substances contingent upon objective evidence of abstinence from substance use. Because CM requires verification of abstinence multiple times daily with a clinic-based carbon monoxide (CO) monitor, it has largely been relegated to inpatient and day treatment programs. The application of emerging smart phone technology, however, can overcome this barrier, and may be particularly well suited to homeless Veterans. The innovative smart phone application has made the use of CM for outpatient smoking cessation portable and feasible. The goal of this comparative effectiveness trial is to evaluate the effectiveness of a combined tele-health and mobile CM intervention that the investigators are calling Abstinence Reinforcement Therapy (ART). The investigators propose to screen 165 and randomize 126 homeless Veteran smokers to either: ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines guideline-based cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for access to smoking cessation aids including choice of pharmacotherapy, and intensive behavioral therapy through mCM. VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated with enrollment in a VA specialty smoking cessation clinic including group counseling, individual telephone counseling, self-help materials, and smoking cessation aids including choice of pharmacotherapy. Specific aims are to: AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at post-treatment, and 3-month and 6-month post-randomization follow-ups. AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted life years (QALY). AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms. Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol abuse) symptoms on treatment outcome across the two conditions.


Criteria:

Inclusion Criteria: - Veteran - Homeless - Enrolled in Durham VA Medical Center for medical care - Current smoker (at least 10 cigarettes per day) - Willing to quit smoking in the next 30 days Exclusion Criteria: - Active substance dependence other than nicotine - Uncontrolled psychotic symptoms - Severely impaired hearing or speech (must be able to respond to telephone calls) - Lack of interest in receiving telephone care - Pregnancy


Study is Available At:


Original ID:

D1301-R


NCT ID:

NCT02245308


Secondary ID:

1828


Study Acronym:


Brief Title:

Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers


Official Title:

Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VA Office of Research and Development


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

133


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jean C Beckham, PhD
Principal Investigator
Durham VA Medical Center, Durham, NC

Study Dates

Start Date:October 1, 2014
Completion Date:September 28, 2018
Completion Type:Actual
Primary Completion Date:March 30, 2018
Primary Completion Type:Actual
Verification Date:November 2019
Last Changed Date:November 19, 2019
First Received Date:September 11, 2014
First Results Date:February 6, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Participants Self-reported and Bioverified Abstinent From Smoking
Time Frame:6 months
Safety Issues:False
Description:Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).
Outcome Type:Secondary Outcome
Measure:Intervention Delivery Costs
Time Frame:6 months
Safety Issues:False
Description:Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.

Study Interventions

Intervention Type:Drug
Name:Nicotine Patches
Description:Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.
Arm Name:ART
Other Name:Nicoderm
Intervention Type:Behavioral
Name:mobile contingency management (mCM)
Description:Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings. Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.
Arm Name:ART
Intervention Type:Behavioral
Name:Smoking cessation counseling
Description:Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
Arm Name:ART
Intervention Type:Drug
Name:Nicotine rescue method
Description:Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.
Arm Name:ART
Other Name:Nicorette
Intervention Type:Drug
Name:Bupropion
Description:Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.
Arm Name:ART
Other Name:Zyban, Wellbutrin

Study Arms

Study Arm Type:Active Comparator
Arm Name:Control Group
Description:Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Study Arm Type:Experimental
Arm Name:ART
Description:Participants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:VA Office of Research and Development

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004 Mar 10;291(10):1238-45. Review. Erratum in: JAMA. 2005 Jan 19;293(3):298. Erratum in: JAMA. 2005 Jan 19;293(3):293-4.
PMID:15010446
Reference Type:Reference
Citation:Tsai J, Edens EL, Rosenheck RA. Nicotine dependence and its risk factors among users of veterans health services, 2008-2009. Prev Chronic Dis. 2011 Nov;8(6):A127. Epub 2011 Oct 17.
PMID:22005620
Reference Type:Reference
Citation:Tsai J, Rosenheck RA. Homeless veterans in supported housing: exploring the impact of criminal history. Psychol Serv. 2013 Nov;10(4):452-8. doi: 10.1037/a0032775. Epub 2013 Sep 30.
PMID:24079354

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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