About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Smoking Cessation
BehavioralFive 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
DrugNRT 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
DrugBupropion is an FDA-approved prescription smoking cessation aid. Participants will be prescribed 150-300 mg.
Varenicline
DrugVarenicline is an FDA-approved prescription smoking cessation aid. Participants will be 0.5 to 2 mg.
Mobile Contingency Management
BehavioralSmoking 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
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
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
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
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
Sponsors and contacts
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