Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Smoking Cessation, Nicotine Replacement Therapy, Bupropion, Varenicline.
- Who it may be relevant to
- Registry conditions: Tobacco Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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+.
Interventions
- 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. - 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). - Drug Bupropion
Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg. - Drug Varenicline
Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg. - 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. - 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.
Primary outcome measures
- Number of participants whose self-report of prolonged smoking abstinence is bioverified [Time frame: 6-month follow-up, about six months after baseline]
Secondary outcome measures (12)
- Number of participants whose self-report of prolonged smoking abstinence is bioverified [Time frame: 3-month follow-up, about three months after baseline]
- Number of participants whose self-report of prolonged smoking abstinence is bioverified [Time frame: 12-month follow-up, about twelve months after baseline]
- Number of participants who self-report 7-day point prevalence abstinence [Time frame: 3-month follow-up, about three months after baseline]
- Number of participants who self-report 7-day point prevalence abstinence [Time frame: 6-month follow-up, about six months after baseline]
- Number of participants who self-report 7-day point prevalence abstinence [Time frame: 12-month follow-up, about twelve months after baseline]
- Number of participants who self-report 30-day point prevalence abstinence [Time frame: 3-month follow-up, about three months after baseline]
- Number of participants who self-report 30-day point prevalence abstinence [Time frame: 6-month follow-up, about six months after baseline]
- Number of participants who self-report 30-day point prevalence abstinence [Time frame: 12-month follow-up, about twelve months after baseline]
- Number of participants who self-report early continuous abstinence [Time frame: 3-month follow-up, about three months after baseline]
- Incremental Cost-Effectiveness Ratio [Time frame: 12 months post quit, about 12 months after baseline]
- Percentage of carbon monoxide reading completion by participants in ART+ intervention group [Time frame: 3-month follow-up, about three months after baseline]
- Number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in ART+ intervention group [Time frame: 3-month follow-up, about three months after baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Durham VA Medical Center, Durham, NC — Durham
Identifiers
NCT: NCT07714200 · HSR2-003-25M · 1924743