Tailored Tobacco Quitline for Rural Veterans

Study Overview
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Brief Summary
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The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are: Study the feasibility of an individually-tailored telephone intervention for rural smokers. Examine the impact of the intervention on tobacco use outcomes. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.

Detailed Description
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Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers. Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care. In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.

Official Title
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Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Drug: Nicotine replacement therapy - transdermal nicotine patch
* Behavioral: Tailored behavioral intervention
* Behavioral: Tobacco quit line referral
* Drug: Nicotine replacement therapy - nicotine gum
* Drug: Nicotine replacement therapy - nicotine lozenge
* Drug: Bupropion Sustained Release
* 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: Alcohol use risk reduction
* Behavioral: Behavioral activation for the treatment of depression
* Behavioral: Behavioral management of post-cessation weight gain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a veteran 18 + years of age Smoke cigarettes on at least a daily basis Receive primary care from the Iowa City VAMC or Coralville Clinic Live in a non-metropolitan area (based on RUCA codes) Be willing to make a quit attempt 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

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 Group<br>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 associated with cigarette smoking. | Drug: Nicotine replacement therapy - transdermal nicotine patch<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications.<br>Behavioral: Tailored behavioral intervention<br>* Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.<br>Drug: Nicotine replacement therapy - nicotine gum<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>Drug: Nicotine replacement therapy - nicotine lozenge<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>Drug: Bupropion Sustained Release<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>* Other names: Zyban;Drug: Varenicline<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>* Other names: Chantix;Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<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>* Other names: Harm reduction;Behavioral: Behavioral activation for the treatment of depression<br>* Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.<br>* Other names: Depression;Behavioral: Behavioral management of post-cessation weight gain<br>* 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.<br>* Other names: Weight management;|
| Active Comparator: Enhanced Standard of Care Group<br>Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation. | Drug: Nicotine replacement therapy - transdermal nicotine patch<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications.<br>Behavioral: Tobacco quit line referral<br>* Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.<br>Drug: Nicotine replacement therapy - nicotine gum<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>Drug: Nicotine replacement therapy - nicotine lozenge<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>Drug: Bupropion Sustained Release<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>* Other names: Zyban;Drug: Varenicline<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>* Other names: Chantix;Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<br>Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion<br>* Medication selection will be determined based on individual participant preferences, medical history, and contraindications<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 the intervention will be assessed by interview at the end of treatment. | End of treatment (seven weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Abstinent From Tobacco Use | At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence). | Six-month follow-up | 
| Alcohol Use | Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group. | Six-month follow-up | 
| Depressive Symptoms | Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms. | Six-month follow-up | 
| Body Weight | Self-reported body weight. | Six-month follow-up | 
| Enrollment Rate | The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period. | 6 months after study initiation | 
| Retention | The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach. | End of treatment (seven weeks after baseline) | 
| Treatment Attendance | The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach. | End of treatment (seven weeks after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol use, Depression, Nicotine dependence, Smoking cessation, Telehealth, Body weight