Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

Mark Vander Weg

Status and phase: Unknown; Phase 3

Conditions: Nicotine Dependence; Tobacco Use

Treatments: Behavioral: Behavioral activation for depressive symptoms; Drug: Nicotine replacement therapy - Nicotine gum; Behavioral: Alcohol use risk reduction; Drug: Nicotine replacement therapy - Nicotine lozenge; Behavioral: Behavioral management of postcessation weight gain; Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion; Drug: Bupropion; Behavioral: Tobacco quitline referral; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge; Drug: Varenicline; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum; Drug: Nicotine replacement therapy - Transdermal nicotine patch; Behavioral: Tailored behavioral intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01892813

201305740

Details and patient eligibility

About

The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.

Enrollment: 411 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Veteran status
• 18 + years of age
• Smoke cigarettes on at least a daily basis
• Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC)
• Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes)
• Be willing to make an attempt to quit smoking in the next 30 days
• Be capable of providing informed consent
• Have access to a telephone (land line or cell phone)
• Have a stable residence

Exclusion criteria

• Planning to move within the next 12 months
• Presence of a terminal illness
• Pregnancy
• Unstable psychiatric disorder (e.g., acute psychosis)
• Currently pregnant
• Incarcerated
• Institutionalized

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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411 participants in 2 patient groups

Tailored intervention

Experimental group

Description:

Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.

Treatment:

Behavioral: Tailored behavioral intervention

Drug: Nicotine replacement therapy - Transdermal nicotine patch

Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum

Drug: Varenicline

Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge

Drug: Bupropion

Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion

Behavioral: Behavioral management of postcessation weight gain

Drug: Nicotine replacement therapy - Nicotine lozenge

Behavioral: Alcohol use risk reduction

Behavioral: Behavioral activation for depressive symptoms

Drug: Nicotine replacement therapy - Nicotine gum

Enhanced standard of care

Active Comparator group

Description:

Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.

Treatment:

Drug: Nicotine replacement therapy - Transdermal nicotine patch

Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum

Drug: Varenicline

Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge

Behavioral: Tobacco quitline referral

Drug: Bupropion

Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion

Drug: Nicotine replacement therapy - Nicotine lozenge

Drug: Nicotine replacement therapy - Nicotine gum