Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness

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+.

• Cognitive Behavioral Therapy for Smoking Cessation (Behavioral), also known as CBT: 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.
• Nicotine Replacement Therapy (Drug), also known as NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette: 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).
• Bupropion (Drug), also known as Zyban: Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.
• Varenicline (Drug), also known as Chantix: Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.
• Mobile Contingency Management (Behavioral), also known as mCM, CM: 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.
• Clinic-Based Smoking Cessation Counseling (Behavioral): 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 outcomes

• Number of participants whose self-report of prolonged smoking abstinence is bioverified [6-month follow-up, about six months after baseline]: 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)

Secondary outcomes

• Number of participants whose self-report of prolonged smoking abstinence is bioverified [3-month follow-up, about three months after baseline]: 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)
• Number of participants whose self-report of prolonged smoking abstinence is bioverified [12-month follow-up, about twelve months after baseline]: 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
• Number of participants who self-report 7-day point prevalence abstinence [3-month follow-up, about three months after baseline]: 7-day point prevalence abstinence is defined as no smoking in the prior 7 days
• Number of participants who self-report 7-day point prevalence abstinence [6-month follow-up, about six months after baseline]: 7-day point prevalence abstinence is defined as no smoking in the prior 7 days
• Number of participants who self-report 7-day point prevalence abstinence [12-month follow-up, about twelve months after baseline]: 7-day point prevalence abstinence is defined as no smoking in the prior 7 days
• Number of participants who self-report 30-day point prevalence abstinence [3-month follow-up, about three months after baseline]: 7-day point prevalence abstinence is defined as no smoking in the prior 30 days
• Number of participants who self-report 30-day point prevalence abstinence [6-month follow-up, about six months after baseline]: 7-day point prevalence abstinence is defined as no smoking in the prior 30 days
• Number of participants who self-report 30-day point prevalence abstinence [12-month follow-up, about twelve months after baseline]: 30-day point prevalence abstinence is defined as no smoking in the prior 30 days
• Number of participants who self-report early continuous abstinence [3-month follow-up, about three months after baseline]: Early continuous abstinence will be defined as reporting two weeks of continuous abstinence during the first four weeks after the quit day
• Incremental Cost-Effectiveness Ratio [12 months post quit, about 12 months after baseline]: Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator.
• Percentage of carbon monoxide reading completion by participants in ART+ intervention group [3-month follow-up, about three months after baseline]: 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.
• Number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in ART+ intervention group [3-month follow-up, about three months after baseline]: 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
• 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]: 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.

Sex: All, ages: 18 Years to any

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

• Jean C Beckham, PhD, Principal investigator, Durham VA Medical Center, Durham, NC