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

NCT07714200 | Not Yet Recruiting

• 2 other identifiers: HSR2-003-25M1924743
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tobacco Use Disorder

Keywords

Smoking; Veterans; Ill-Housed Persons

Outcome Measures

Primary Outcomes (1)

• 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)

  6-month follow-up, about six months after baseline

Secondary Outcomes (13)

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

  3-month follow-up, about three months after baseline

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

  12-month follow-up, about twelve months after baseline

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

  3-month follow-up, about three months after baseline

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

  6-month follow-up, about six months after baseline

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

  12-month follow-up, about twelve months after baseline

Study Arms (2)

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.

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.

Drug: Nicotine Replacement Therapy; Drug: Bupropion; Drug: Varenicline; Behavioral: Clinic-Based Smoking Cessation Counseling

Interventions

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).

Also known as: NRT, nicotine gum, nicotine lozenge, nicotine patch, NicoDerm, Nicorette

Abstinence Reinforcement Therapy +; Standard Care Condition

Varenicline DRUG

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

Also known as: Chantix

Abstinence Reinforcement Therapy +; Standard Care Condition

Bupropion DRUG

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

Also known as: Zyban

Abstinence Reinforcement Therapy +; Standard Care Condition

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.

Standard Care Condition

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.

Also known as: CBT

Abstinence Reinforcement Therapy +

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.

Also known as: mCM, CM

Abstinence Reinforcement Therapy +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Cognitive Behavioral Therapy; Nicotine Replacement Therapy; Nicotine Chewing Gum; Tobacco Use Cessation Devices; Nicotine; Bupropion; Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Drug Therapy; Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines

Study Officials

• Jean C Beckham, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela C Kirby, MS

CONTACT

(919) 286-0411; angela.kirby@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)