An interventional study of Cognitive Behavioral Therapy for Smoking Cessation and Nicotine Replacement Therapy in Tobacco Use Disorder, sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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Among 17 studies in Tobacco Use Disorder by VA Office of Research and Development — 5 open to participants now, 6 under way, none of them phase 3. Tobacco Use Disorder · VA Office of Research and Development.
Among the 17 studies in Tobacco Use Disorder by VA Office of Research and Development, this one is the 10th largest by planned enrollment of the 16 interventional ones that give a count, is the only one that started in 2027, is one of 10 with no phase, and was the 17th registered.
1,028 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
Browse Tobacco Use Disorder studies →5 of the 17 studies in Tobacco Use Disorder by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Ages 21+
VA Office of Research and Development · Sites in United States
VA Office of Research and Development · Sites in United States
Ages 18+ · Healthy volunteers
VA Office of Research and Development · Sites in United States
Ages 18–75
By country, each count listing its studies:
Of the 95 Tobacco Use Disorder studies recruiting now, 42 (44%) set no upper age limit and 50 (53%) stop at 75 or younger; 6 take children under 18; 37 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2027.
This study's planned enrollment of 120 is above the median of 90 across 893 interventional studies indexed under Tobacco Use Disorder.
Median enrollment 128 across the 16 interventional studies, 109 across the 1 observational. Of the 10 that completed or were terminated, 9 (90%) have results posted.
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VA Office of Research and Development is the lead sponsor of 1,773 studies on the registry; 393 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
2 of the studies in Tobacco Use Disorder by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03477435VA Office of Research and DevelopmentComparing an Opt-out to an opt-in Approach for Smoking Cessation in VA Primary Care Clinics | 2027-04-01 |
| NCT05723588VA Office of Research and DevelopmentNeuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD | 2027-11-01 |
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Among the 17 studies in Tobacco Use Disorder by VA Office of Research and Development, from their registry updates:
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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.
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+.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Drug: Nicotine Replacement Therapy · Drug: Bupropion · Drug: Varenicline · Behavioral: Mobile Contingency Management
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 · Drug: Bupropion · Drug: Varenicline · Behavioral: Clinic-Based Smoking Cessation Counseling
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.
Also known as: CBT
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).
Also known as: NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette
Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.
Also known as: Zyban
Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.
Also known as: Chantix
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.
Also known as: mCM, CM
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.
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)
Time frame: 6-month follow-up, about six 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
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
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
Time frame: 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.
Time frame: 3-month follow-up, about three months after baseline
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Mar 2030, 36 months later.
Of 257 non-industry interventional studies with no phase under Tobacco Use Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 36 months is close to that.
Counting every sponsor, half of 267 studies reached it within 32 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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