Treating Smokeless Tobacco Use in Rural Veterans

Mark Vander Weg

Status: Unknown

Conditions: Smokeless Tobacco; Nicotine Dependence

Treatments: Behavioral: Tailored behavioral intervention; Behavioral: Alcohol use risk reduction; Drug: Combination nicotine replacement therapy; Drug: Bupropion sustained release; Behavioral: Post-cessation weight gain management; Drug: Combination nicotine replacement therapy + bupropion; Behavioral: Educational materials; Drug: Nicotine replacement therapy - transdermal nicotine patch; Drug: Nicotine replacement therapy - nicotine gum; Drug: Varenicline; Behavioral: Behavioral activation for elevated depressive symptoms; Behavioral: Tobacco quit line; Drug: Nicotine replacement therapy - nicotine lozenge

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02994082

201611737

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Use smokeless tobacco on a daily basis
2. Be willing to make a quit attempt in the next 30 days
3. Reside in a rural location
4. Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic
5. Able to provide informed consent
6. Telephone access
7. Stable residence

Exclusion criteria

1. Planning to move in the next 12 months
2. Terminal illness
3. Unstable psychiatric disorder
4. Incarcerated
5. Institutionalized

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups

Tailored Intervention

Experimental group

Description:

The tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences.

Treatment:

Behavioral: Tailored behavioral intervention

Drug: Nicotine replacement therapy - nicotine lozenge

Drug: Varenicline

Behavioral: Behavioral activation for elevated depressive symptoms

Drug: Nicotine replacement therapy - nicotine gum

Drug: Nicotine replacement therapy - transdermal nicotine patch

Behavioral: Alcohol use risk reduction

Drug: Combination nicotine replacement therapy + bupropion

Drug: Combination nicotine replacement therapy

Drug: Bupropion sustained release

Behavioral: Post-cessation weight gain management

Facilitated tobacco quit line referral

Active Comparator group

Description:

Participants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options.

Treatment:

Behavioral: Educational materials

Behavioral: Tobacco quit line