Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness | NCT07714200

NCT07714200

Overview

NCT ID: NCT07714200
Lead Sponsor: VA Office of Research and DevelopmentFED
Official Title: Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Mar 1, 2027Estimated
Primary Completion Date: Mar 1, 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Angela C Kirby, MSContact
angela.kirby@va.gov(919) 286-0411 ext. 7456

Similar Studies

Participant Group/Arms

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 ConditionActive 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