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NCT Number: NCT07714200

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location contact

Angela C Kirby, MS

CONTACT

[email protected]

919-286-0411 ext. 7456

Jean C Beckham, PhD

PRINCIPAL_INVESTIGATOR

About this study

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+.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral therapy for smoking cessation

Behavioral

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

Nicotine Replacement Therapy

Drug

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

bupropion

Drug

Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.

Other names: Zyban

Varenicline

Drug

Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.

Other names: Chantix

Mobile Contingency Management

Behavioral

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

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

  1. Number of participants whose self-report of prolonged smoking abstinence is bioverified

    Time frame: 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

  1. Number of participants whose self-report of prolonged smoking abstinence is bioverified

    Time frame: 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)

  2. Number of participants whose self-report of prolonged smoking abstinence is bioverified

    Time frame: 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

  3. Number of participants who self-report 7-day point prevalence abstinence

    Time frame: 3-month follow-up, about three months after baseline

    7-day point prevalence abstinence is defined as no smoking in the prior 7 days

  4. Number of participants who self-report 7-day point prevalence abstinence

    Time frame: 6-month follow-up, about six months after baseline

    7-day point prevalence abstinence is defined as no smoking in the prior 7 days

  5. Number of participants who self-report 7-day point prevalence abstinence

    Time frame: 12-month follow-up, about twelve months after baseline

    7-day point prevalence abstinence is defined as no smoking in the prior 7 days

  6. Number of participants who self-report 30-day point prevalence abstinence

    Time frame: 3-month follow-up, about three months after baseline

    7-day point prevalence abstinence is defined as no smoking in the prior 30 days

  7. Number of participants who self-report 30-day point prevalence abstinence

    Time frame: 6-month follow-up, about six months after baseline

    7-day point prevalence abstinence is defined as no smoking in the prior 30 days

  8. Number of participants who self-report 30-day point prevalence abstinence

    Time frame: 12-month follow-up, about twelve months after baseline

    30-day point prevalence abstinence is defined as no smoking in the prior 30 days

  9. Number of participants who self-report early continuous abstinence

    Time frame: 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

  10. Incremental Cost-Effectiveness Ratio

    Time frame: 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.

  11. Percentage of carbon monoxide reading completion by participants in ART+ intervention group

    Time frame: 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.

  12. 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

    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

  13. Number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angela C Kirby, MS

CONTACT

[email protected]

(919) 286-0411 ext. 7456

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: New HART

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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