Treating Smokeless Tobacco Use in Rural Veterans

Summary

This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. The objectives are to:

1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users
2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.

Conditions

• Smokeless Tobacco
• Nicotine Dependence

Interventions

BEHAVIORAL

Tailored behavioral intervention

Participants will receive a standard six session cognitive behavioral intervention for smokeless tobacco cessation combined with supplemental treatment modules based on individual need and preferences.

BEHAVIORAL

Behavioral activation for elevated depressive symptoms

Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.

BEHAVIORAL

Post-cessation weight gain management

Participants with concerns about gaining weight after quitting smokeless tobacco use may receive this six session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.

BEHAVIORAL

Alcohol use risk reduction

Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.

DRUG

Nicotine replacement therapy - transdermal nicotine patch

Medication selection will be based on individual participant preferences, medical history, and contraindications.

DRUG

Nicotine replacement therapy - nicotine lozenge

Medication selection will be based on individual participant preferences, medical history, and contraindications.

DRUG

Nicotine replacement therapy - nicotine gum

Medication selection will be based on individual participant preferences, medical history, and contraindications.

DRUG

Bupropion sustained release

Medication selection will be based on individual participant preferences, medical history, and contraindications.

DRUG

Varenicline

Medication selection will be based on individual participant preferences, medical history, and contraindications.

DRUG

Combination nicotine replacement therapy

Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.

DRUG

Combination nicotine replacement therapy + bupropion

Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.

BEHAVIORAL

Tobacco quit line

Referral to the Department of Veterans Affairs tobacco telephone quit line.

BEHAVIORAL

Educational materials

Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,

Sponsors & Collaborators

• Iowa City VA Health Care System

  collaborator FED

• Mark Vander Weg

  lead FED

Principal Investigators

• Mark W. Vander Weg, PhD · Iowa City VA Health Care System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2019-09-30

Completion

2020-05-31

Countries

• United States

Study Locations