Treating Smokeless Tobacco Use in Rural Veterans

Study Overview
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Brief Summary
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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: Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.

Official Title
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Treating Smokeless Tobacco Use in Rural Veterans

Conditions
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Smokeless Tobacco, Nicotine Dependence

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Use smokeless tobacco on a daily basis Be willing to make a quit attempt in the next 30 days Reside in a rural location Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic Able to provide informed consent Telephone access Stable residence Exclusion Criteria: Planning to move in the next 12 months Terminal illness Unstable psychiatric disorder Incarcerated Institutionalized

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Intervention<br>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. | Behavioral: Tailored behavioral intervention<br>* Participants will receive a standard six session cognitive behavioral intervention for smokeless tobacco cessation combined with supplemental treatment modules based on individual need and preferences.<br>Behavioral: Behavioral activation for elevated depressive symptoms<br>* Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.<br>Behavioral: Post-cessation weight gain management<br>* Participants with concerns about gaining weight after quitting smokeless tobacco use may receive this six session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.<br>Behavioral: Alcohol use risk reduction<br>* Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.<br>Drug: Nicotine replacement therapy - transdermal nicotine patch<br>* Medication selection will be based on individual participant preferences, medical history, and contraindications.<br>* Other names: Nicotine patch;Drug: Nicotine replacement therapy - nicotine lozenge<br>* Medication selection will be based on individual participant preferences, medical history, and contraindications.<br>* Other names: Nicotine lozenge;Drug: Nicotine replacement therapy - nicotine gum<br>* Medication selection will be based on individual participant preferences, medical history, and contraindications.<br>* Other names: Nicotine gum;Drug: Bupropion sustained release<br>* Medication selection will be based on individual participant preferences, medical history, and contraindications.<br>* Other names: Zyban;Drug: Varenicline<br>* Medication selection will be based on individual participant preferences, medical history, and contraindications.<br>* Other names: Chantix;Drug: Combination nicotine replacement therapy<br>* Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.<br>Drug: Combination nicotine replacement therapy + bupropion<br>* Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.<br>* Other names: Medication selection will be based on individual participant preferences, medical history, and contraindications.;|
| Active Comparator: Facilitated tobacco quit line referral<br>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. | Behavioral: Tobacco quit line<br>* Referral to the Department of Veterans Affairs tobacco telephone quit line.<br>Behavioral: Educational materials<br>* Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction | Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview. | Three month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco use | At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use. | Three-and six-month follow-up | 
| Alcohol use | Alcohol use during the previous seven days. | Three- and six-month follow-up | 
| Depressive symptoms | Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9) | Three- and six-month follow-up | 
| Body weight | Body weight will be assessed via self-report. | Three- and six-month follow-up | 
| Enrollment rate | The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach. | Six months after study initiation | 
| Retention | The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach. | Six months after study initiation | 
| Treatment attendance | The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach. | Three-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rural health, Veterans, Smokeless tobacco cessation