Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers
Phase 3
- Conditions
- Tobacco UseNicotine Dependence
- Interventions
- Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gumDrug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozengeDrug: Combination pharmacotherapy - Transdermal nicotine patch + bupropionBehavioral: Tailored behavioral interventionBehavioral: Tobacco quitline referralBehavioral: Alcohol use risk reductionBehavioral: Behavioral activation for depressive symptomsBehavioral: Behavioral management of postcessation weight gain
- Registration Number
- NCT01892813
- Lead Sponsor
- Mark Vander Weg
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 411
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tailored intervention Nicotine replacement therapy - Transdermal nicotine patch 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. Enhanced standard of care Nicotine replacement therapy - Transdermal nicotine patch 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. Tailored intervention Nicotine replacement therapy - Nicotine gum 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. Enhanced standard of care Nicotine replacement therapy - Nicotine lozenge 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. Tailored intervention Varenicline 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. Tailored intervention Nicotine replacement therapy - Nicotine lozenge 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. Tailored intervention Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum 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. Tailored intervention Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge 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. Tailored intervention Combination pharmacotherapy - Transdermal nicotine patch + bupropion 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. Tailored intervention Tailored behavioral intervention 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. Tailored intervention Alcohol use risk reduction 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. Enhanced standard of care Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge 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. Tailored intervention Behavioral activation for depressive symptoms 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. Tailored intervention Behavioral management of postcessation weight gain 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. Enhanced standard of care Nicotine replacement therapy - Nicotine gum 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. Enhanced standard of care Combination pharmacotherapy - Transdermal nicotine patch + bupropion 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. Enhanced standard of care Varenicline 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. Enhanced standard of care Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum 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. Enhanced standard of care Tobacco quitline referral 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. Tailored intervention Bupropion 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. Enhanced standard of care Bupropion 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.
- Primary Outcome Measures
Name Time Method Tobacco use Six-month follow-up At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days.
- Secondary Outcome Measures
Name Time Method Alcohol use Six-month follow-up Alcohol use during the previous seven days will be assessed at the six month follow-up. Based on this information, several metrics of alcohol consumption will be obtained including: 1) average number of drinking days per week, 2) average number of drinks per drinking day, 3) number of drinks per week 4) number of heavy drinking days, and 5) maximum drinks consumed on a single occasion.
Depressive symptoms Six-month follow-up Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9).
Body weight Six-month follow-up Change in body weight will be assessed via self-report and chart review at the six-month follow-up.
Physical Activity Six-month follow-up Physical activity will be assessed by self-report at the six-month follow-up visit using the Rapid Assessment of Physical Activity (RAPA).
Dietary intake Six-month follow-up Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire.
Trial Locations
- Locations (1)
Iowa City VA Healthcare System
🇺🇸Iowa City, Iowa, United States