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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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).

  • Bupropion

    Drug

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

  • Varenicline

    Drug

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

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Abstinence Reinforcement Therapy +Experimental treatment 5 interventions
Group B: Standard Care ConditionActive comparator 4 interventions

Trial outcomes

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)

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

Secondary 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)

Time frame
3-month follow-up, about three months after baseline
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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