Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness (New HART)

Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans. Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people. The purpose of this study study is to evaluate the effectiveness of an intervention to help Veterans experiencing homelessness stop smoking. The intervention, called Abstinence Reinforcement Therapy + (ART+), includes telehealth-based counseling, smoking cessation aids, and mobile contingency management (mCM). mCM is an intervention in which participants are paid for smoking abstinence. 120 Veterans who smoke cigarettes and are experiencing homelessness will be randomly assigned to receive either ART+ or usual smoking cessation care. The primary outcome to be evaluated is the rate at which Veterans assigned to the ART+ condition report smoking abstinence and have their abstinence verified using salivary testing.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Smoking Cessation; Drug: Nicotine Replacement Therapy; Drug: Bupropion; Drug: Varenicline; Behavioral: Mobile Contingency Management; Behavioral: Clinic-Based Smoking Cessation Counseling

Detailed Description

Significance to VA: Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans. Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people. While there are numerous challenges to smoking cessation among Veterans experiencing homelessness, four in five homeless smokers report interest in quitting. Innovation and Impact: The investigators recently developed and evaluated the effectiveness of a multi-component intervention called Abstinence Reinforcement Therapy (ART), which combined five sessions of telehealth-based cognitive-behavioral therapy, provision of smoking cessation aids, and four weeks of mobile contingency management (mCM). The investigators have added an additional CM period of eight weeks and opportunities for booster calls and repeated quit attempts, resulting in an intervention called ART+ to improve outcomes over time. The innovative use of web-based platform technology in the current proposal will remove numerous barriers that often prevent smokers experiencing homelessness from accessing high-quality, evidence-based care. There is tremendous inequity in smoking-related outcomes for VEH. The innovative use of mobile health technology in the current proposal will remove numerous barriers that often prevent Veterans who smoke and experience homelessness from accessing high- quality, evidence-based care. Specific Aims: Aim 1: Evaluate the comparative effectiveness of ART+ on bio-verified abstinence outcomes at three-, six-and 12-month follow-ups. The primary endpoint will be bioverified prolonged abstinence at the six-month follow-up. Aim 2: Assess the relative cost-effectiveness of ART+ to VA standard care smoking cessation on quality adjusted life years (QALY). Aim 3: Qualitatively evaluate implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs. Methodology: 120 Veterans experiencing homelessness who smoke cigarettes will be randomly assigned to ART+ or to VA standard smoking cessation care. Self-reported and bioverified abstinence at six months are the primary outcomes. Cost-effectiveness analyses will be performed using QALY as the effectiveness measure. Rapid qualitative analytic methods will be used to evaluate implementation determinants of ART+ following enrollment of all study participants. Participants for the qualitative analysis will include clinicians and clinical support staff who provide care to Veterans experiencing homelessness, designated VA operations partners, and VA Tobacco Treatment Specialists. Purposive sampling will be used to identify potential participants and a structured interview guide based upon domains from the Consolidated Framework for Implementation Research (CFIR) will be administered. The investigators will use rapid qualitative analysis to answer the key qualitative research question: "What determinants will impact implementation of ART+?" The benefit of decreasing tobacco use (Aim 1) among VEH who smoke is tremendous as it will prevent significant morbidity and mortality. Moreover, if ART+ is shown to be cost effective (Aim 2) and implementation determinants are identified (Aim 3), the use of mobile phones as a platform to provide behavioral incentives has the potential to transform the delivery of smoking cessation care. Path to Translation/Implementation: Cost-effectiveness analysis (Aim 2) will help guide implementation decisions. Qualitative evaluation of the implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs (Aim 3) will provide important information on effective implementation of ART+.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela C Kirby, MS; Phone Number: 7456 (919) 286-0411; Email: angela.kirby@va.gov

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC
      • Contact: Angela C Kirby, MS; Phone Number: 7456 919-286-0411; Email: angela.kirby@va.gov
      • Principal Investigator: Jean C Beckham, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Are homeless
• Smoke at least 5 cigarettes daily with CO indicating current smoking at time of screening assessment
• Are willing to try to quit smoking in next 30 days

Exclusion Criteria:

• Have uncontrolled psychotic symptoms
• Have active substance dependence other than nicotine (participants in partial remission with at least one month sobriety will be included)
• Have severely impaired hearing or speech

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abstinence Reinforcement Therapy +; Abstinence Reinforcement Therapy +, or ART+, includes five sessions and several booster sessions of cognitive-behavioral therapy for smoking cessation, two forms of nicotine replacement therapy plus bupropion or varenicline, and mobile contingency management for smoking cessation.	Behavioral: Cognitive Behavioral Therapy for Smoking Cessation; Five core sessions of CBT plus up to four monthly booster sessions designed to help Veterans prepare to quit smoking, make a quit attempt, and prevent relapse to smoking.; Other Names: CBT; Drug: Nicotine Replacement Therapy; NRT is a group of over-the-counter medications designed to help users quit smoking. Standard of care often involves use of nicotine patch plus one rescue method (either gum or lozenge).; Other Names: NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette; Drug: Bupropion; Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.; Other Names: Zyban; Drug: Varenicline; Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.; Other Names: Chantix; Behavioral: Mobile Contingency Management; Smoking abstinence will be intermittently reinforced. For each carbon monoxide (CO) reading that a participant provides that suggest smoking abstinence, the participant will earn spins on a virtual prize wheel that has financial prizes.; Other Names: mCM, CM
Active Comparator: Standard Care Condition; Standard Care Condition will involve referral to local VA clinic-based smoking cessation care. This care often includes pharmacotherapy, counseling options, and/or use of a telephone-based, texting-based or app-based smoking cessation program.	Drug: Nicotine Replacement Therapy; NRT is a group of over-the-counter medications designed to help users quit smoking. Standard of care often involves use of nicotine patch plus one rescue method (either gum or lozenge).; Other Names: NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette; Drug: Bupropion; Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.; Other Names: Zyban; Drug: Varenicline; Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.; Other Names: Chantix; Behavioral: Clinic-Based Smoking Cessation Counseling; Participants assigned to the usual care condition may participate in group counseling for smoking cessation, which can also include use of phone-based smoking cessation resources such as a telephone quit line, a texting program, and a smoking cessation app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants whose self-report of prolonged smoking abstinence is bioverified	Prolonged abstinence is defined as 30 days abstinent. For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL)	6-month follow-up, about six months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants whose self-report of prolonged smoking abstinence is bioverified	Prolonged abstinence is defined as 30 days abstinent. For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL)	3-month follow-up, about three months after baseline
Number of participants whose self-report of prolonged smoking abstinence is bioverified	Prolonged abstinence is defined as 30 days abstinent. For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL	12-month follow-up, about twelve months after baseline
Number of participants who self-report 7-day point prevalence abstinence	7-day point prevalence abstinence is defined as no smoking in the prior 7 days	3-month follow-up, about three months after baseline
Number of participants who self-report 7-day point prevalence abstinence	7-day point prevalence abstinence is defined as no smoking in the prior 7 days	6-month follow-up, about six months after baseline
Number of participants who self-report 7-day point prevalence abstinence	7-day point prevalence abstinence is defined as no smoking in the prior 7 days	12-month follow-up, about twelve months after baseline
Number of participants who self-report 30-day point prevalence abstinence	7-day point prevalence abstinence is defined as no smoking in the prior 30 days	3-month follow-up, about three months after baseline
Number of participants who self-report 30-day point prevalence abstinence	7-day point prevalence abstinence is defined as no smoking in the prior 30 days	6-month follow-up, about six months after baseline
Number of participants who self-report 30-day point prevalence abstinence	30-day point prevalence abstinence is defined as no smoking in the prior 30 days	12-month follow-up, about twelve months after baseline
Number of participants who self-report early continuous abstinence	Early continuous abstinence will be defined as reporting two weeks of continuous abstinence during the first four weeks after the quit day	3-month follow-up, about three months after baseline
Incremental Cost-Effectiveness Ratio	Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator.	12 months post quit, about 12 months after baseline
Percentage of carbon monoxide reading completion by participants in ART+ intervention group	Patient intervention utilization will be measured by the percentage of prompted carbon monoxide readings that participants in the ART+ condition complete during the treatment period.	3-month follow-up, about three months after baseline
Number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in ART+ intervention group	Patient intervention utilization will be measured by the number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in the ART+ condition during the treatment period	3-month follow-up, about three months after baseline
Number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period	Patient intervention utilization will be measured by the number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period.	3-month follow-up, about three months after baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jean C Beckham, PhD, Durham VA Medical Center, Durham, NC

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Smoking; Veterans; Ill-Housed Persons
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Tobacco Use Disorder; Smoking; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Therapy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carbohydrates; Alkaloids; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Polymers; Macromolecular Substances; Polysaccharides; Benzazepines; Ketones; Biopolymers; Quinoxalines; Plant Gums; Candy; Solanaceous Alkaloids; Chewing Gum; Propiophenones; Varenicline; Nicotine; Bupropion; Cognitive Behavioral Therapy; Tobacco Use Cessation Devices; Nicotine Replacement Therapy; Nicotine Chewing Gum
• Other Study ID Numbers: HSR2-003-25M; 1924743 (Other Identifier: Durham VA Medical Center IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No