Tobacco Use DisorderNew HARTNCT07714200
Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness
A study testing Cognitive Behavioral Therapy for Smoking Cessation, Nicotine Replacement Therapy and Bupropion in people with Tobacco Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Cognitive Behavioral Therapy for Smoking Cessation, Nicotine Replacement Therapy and Bupropion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Angela C Kirby, MS, 919-286-0411 ext. 7456, angela.kirby@va.gov
Jean C Beckham, PhD
About this study
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.
Read the 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+.
- Conditions
- Tobacco Use Disorder
- Being tested
- Cognitive Behavioral Therapy for Smoking Cessation, Nicotine Replacement Therapy, Bupropion, Varenicline, Mobile Contingency Management
- Keywords
- Smoking, Veterans, Ill-Housed Persons
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Smoking CessationBehavioural
Also called 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 TherapyDrug
Also called 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).
BupropionDrug
Also called Zyban
Bupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.
VareniclineDrug
Also called Chantix
Varenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.
Mobile Contingency ManagementBehavioural
Also called 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 CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Abstinence Reinforcement Therapy + | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy for Smoking Cessation; Drug: Nicotine Replacement Therapy; Drug: Bupropion; Drug: Varenicline; Behavioral: Mobile Contingency Management |
| Standard Care Condition | Active comparator | 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. Receives: Drug: Nicotine Replacement Therapy; Drug: Bupropion; Drug: Varenicline; Behavioral: Clinic-Based Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6-month follow-up, about six months after baseline
Secondary outcomes (13)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 3-month follow-up, about three months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jean C Beckham, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714200
- Sponsor's protocol ID
- HSR2-003-25M
- Other IDs
- 1924743
- Acronym
- New HART
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness
- ClinicalTrials.gov ID
- NCT07714200
- Acronym / sponsor ID
- New HART / HSR2-003-25M
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking, Veterans, Ill-Housed Persons
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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+.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abstinence Reinforcement Therapy + | Experimental | Behavioral: Cognitive Behavioral Therapy for Smoking Cessation, Drug: Nicotine Replacement Therapy, Drug: Bupropion, Drug: Varenicline, Behavioral: Mobile Contingency ManagementAbstinence 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. |
| Standard Care Condition | Active comparator | Drug: Nicotine Replacement Therapy, Drug: Bupropion, Drug: Varenicline, Behavioral: Clinic-Based Smoking Cessation CounselingStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Smoking CessationAlso: CBTFive 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. | Behavioural | Abstinence Reinforcement Therapy + |
| Nicotine Replacement TherapyAlso: NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, NicoretteNRT 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 | Abstinence Reinforcement Therapy +, Standard Care Condition |
| BupropionAlso: ZybanBupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg. | Drug | Abstinence Reinforcement Therapy +, Standard Care Condition |
| VareniclineAlso: ChantixVarenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg. | Drug | Abstinence Reinforcement Therapy +, Standard Care Condition |
| Mobile Contingency ManagementAlso: mCM, CMSmoking 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. | Behavioural | Abstinence Reinforcement Therapy + |
| Clinic-Based Smoking Cessation CounselingParticipants 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. | Behavioural | Standard Care Condition |
Primary outcome
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)
13 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Disorder
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean C Beckham, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Smoking Cessation, Nicotine Replacement Therapy and Bupropion in people with Tobacco Use Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela C Kirby, MS ((919) 286-0411 ext. 7456, angela.kirby@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants whose self-report of prolonged smoking abstinence is bioverified (time frame: 6-month follow-up, about six months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.