Tailored Tobacco Intervention
Overview
- Phase
- Phase 3
- Intervention
- Nicotine replacement therapy - Transdermal nicotine patch
- Conditions
- Nicotine Dependence
- Sponsor
- Mark Vander Weg
- Enrollment
- 411
- Locations
- 1
- Primary Endpoint
- Tobacco use
- Last Updated
- 8 years ago
Overview
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.
Investigators
Mark Vander Weg
Associate Professor of Internal Medicine
University of Iowa
Eligibility Criteria
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
Arms & Interventions
Tailored 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.
Intervention: Nicotine replacement therapy - Transdermal nicotine patch
Tailored 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.
Intervention: Nicotine replacement therapy - Nicotine gum
Tailored 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.
Intervention: Nicotine replacement therapy - Nicotine lozenge
Tailored 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.
Intervention: Bupropion
Tailored 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.
Intervention: Varenicline
Tailored 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.
Intervention: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Tailored 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.
Intervention: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Tailored 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.
Intervention: Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Tailored 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.
Intervention: Tailored behavioral intervention
Tailored 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.
Intervention: Alcohol use risk reduction
Tailored 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.
Intervention: Behavioral activation for depressive symptoms
Tailored 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.
Intervention: Behavioral management of postcessation weight gain
Enhanced standard of care
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.
Intervention: Nicotine replacement therapy - Transdermal nicotine patch
Enhanced standard of care
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.
Intervention: Nicotine replacement therapy - Nicotine gum
Enhanced standard of care
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.
Intervention: Nicotine replacement therapy - Nicotine lozenge
Enhanced standard of care
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.
Intervention: Bupropion
Enhanced standard of care
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.
Intervention: Varenicline
Enhanced standard of care
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.
Intervention: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Enhanced standard of care
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.
Intervention: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Enhanced standard of care
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.
Intervention: Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Enhanced standard of care
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.
Intervention: Tobacco quitline referral
Outcomes
Primary Outcomes
Tobacco use
Time Frame: 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 Outcomes
- Alcohol use(Six-month follow-up)
- Depressive symptoms(Six-month follow-up)
- Body weight(Six-month follow-up)
- Physical Activity(Six-month follow-up)
- Dietary intake(Six-month follow-up)