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

Conditions

• Tobacco Use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Jul 20, 2026

Start date

Mar 1, 2027

Status verified

Jul 2026

Primary completion

Mar 1, 2030

Completion

Sep 1, 2030

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Abstinence Reinforcement Therapy +
  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.
• Active Comparator: Standard Care Condition
  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.

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 ]

Central Contacts

• Angela C Kirby, MS
  (919) 286-0411
  [email protected]

Locations (1)

Find similar trials in Durham, NC

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