A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Iowa City Veterans Affairs Medical Center

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Tobacco Cessation

Treatments: Drug: Tobacco cessation pharmacotherapy; Behavioral: Tailored behavioral counseling

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04501016

IowacityVAMC

Details and patient eligibility

About

Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to augment the investigators' existing tailored tobacco treatment intervention.

Full description

Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of tobacco) from the Iowa City VA Health Care System will be proactively recruited using information obtained from the electronic medical record. All participants will receive the investigators' tailored, six session smoking cessation intervention developed over a series of projects funded by ORH. This includes a counseling protocol tailored to tobacco users' individual needs and associated risk factors as well as pharmacotherapy selected using shared decision making. Participants who are unable to quit initially will be provided with enhanced counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit using tobacco during the initial treatment phase will be given an extended, four-session counseling protocol that incorporates new content based on established interventions from positive psychology in an effort to reduce relapse.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Use tobacco (cigarettes, smokeless tobacco, pipes, cigars, hookah) on a daily basis
• Be willing to make a quit attempt in the next 30 days
• Able to provide informed consent
• Have access to a telephone
• Have a stable residence,

Exclusion criteria

• Planning to move within the next 6 months
• Terminal illness
• Unstable psychiatric disorder (e.g., acute psychosis)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Tailored Intervention

Experimental group

Description:

Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.

Treatment:

Drug: Tobacco cessation pharmacotherapy

Behavioral: Tailored behavioral counseling