Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

Tailored Tobacco Intervention

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.

Study Overview

• Status: Unknown
• Conditions: Tobacco Use; Nicotine Dependence
• Intervention / Treatment: Drug: Nicotine replacement therapy - Transdermal nicotine patch; Drug: Nicotine replacement therapy - Nicotine gum; Drug: Nicotine replacement therapy - Nicotine lozenge; Drug: Bupropion; Drug: Varenicline; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge; Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion; Behavioral: Tailored behavioral intervention; Behavioral: Alcohol use risk reduction; Behavioral: Behavioral activation for depressive symptoms; Behavioral: Behavioral management of postcessation weight gain; Behavioral: Tobacco quitline referral

• Study Type: Interventional
• Enrollment (Actual): 411
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52246
      • Iowa City VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Nicotine replacement therapy - Transdermal nicotine patch; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Drug: Nicotine replacement therapy - Nicotine gum; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Other Names: Nicotine polacrilix; Drug: Nicotine replacement therapy - Nicotine lozenge; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Other Names: Nicotine polacrilix; Drug: Bupropion; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Other Names: Zyban; Drug: Varenicline; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Other Names: Chantix; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Behavioral: Tailored behavioral intervention; Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.; Behavioral: Alcohol use risk reduction; Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.; Other Names: Harm reduction; Behavioral: Behavioral activation for depressive symptoms; Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.; Behavioral: Behavioral management of postcessation weight gain; Participants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.; Other Names: Weight management
Active Comparator: 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.	Drug: Nicotine replacement therapy - Transdermal nicotine patch; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Drug: Nicotine replacement therapy - Nicotine gum; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Other Names: Nicotine polacrilix; Drug: Nicotine replacement therapy - Nicotine lozenge; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Other Names: Nicotine polacrilix; Drug: Bupropion; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Other Names: Zyban; Drug: Varenicline; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Other Names: Chantix; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion; Medication selection will be determined based on individual participant preferences, medical history, and contraindications.; Behavioral: Tobacco quitline referral; Participants assigned to this condition will receive a referral to their state tobacco quitline. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco use	At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days.	Six-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol use	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.	Six-month follow-up
Depressive symptoms	Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9).	Six-month follow-up
Body weight	Change in body weight will be assessed via self-report and chart review at the six-month follow-up.	Six-month follow-up
Physical Activity	Physical activity will be assessed by self-report at the six-month follow-up visit using the Rapid Assessment of Physical Activity (RAPA).	Six-month follow-up
Dietary intake	Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire.	Six-month follow-up

Collaborators and Investigators

• Sponsor: Mark Vander Weg
• Collaborators: VA Office of Research and Development
• Investigators: Principal Investigator: Mark W. Vander Weg, Ph.D., VRHRC-CR

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 4, 2013

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Telehealth; Smoking cessation; Alcohol use; Body weight; Nicotine dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion; Varenicline
• Other Study ID Numbers: 201305740