Tailored Tobacco Quitline for Rural Veterans

Iowa City Veterans Affairs Medical Center

Status and phase: Completed; Phase 2

Conditions: Cigarette Smoking

Treatments: Drug: Nicotine replacement therapy - transdermal nicotine patch; Behavioral: Alcohol use risk reduction; Drug: Nicotine replacement therapy - nicotine gum; Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion; Drug: Varenicline; Behavioral: Tobacco quit line referral; Behavioral: Behavioral activation for the treatment of depression; Drug: Nicotine replacement therapy - nicotine lozenge; Behavioral: Tailored behavioral intervention; Behavioral: Behavioral management of post-cessation weight gain; Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge; Drug: Bupropion Sustained Release; Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01592695

201203712

Details and patient eligibility

About

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:

1. Study the feasibility of an individually-tailored telephone intervention for rural smokers.
2. Examine the impact of the intervention on tobacco use outcomes.
3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.

Full description

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups

Tailored Intervention Group

Experimental group

Description:

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.

Treatment:

Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge

Drug: Bupropion Sustained Release

Behavioral: Behavioral management of post-cessation weight gain

Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion

Behavioral: Behavioral activation for the treatment of depression

Drug: Nicotine replacement therapy - nicotine lozenge

Drug: Varenicline

Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum

Drug: Nicotine replacement therapy - transdermal nicotine patch

Behavioral: Tailored behavioral intervention

Drug: Nicotine replacement therapy - nicotine gum

Behavioral: Alcohol use risk reduction

Enhanced Standard of Care Group

Active Comparator group

Description:

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.

Treatment:

Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge

Drug: Bupropion Sustained Release

Drug: Combination pharmacotherapy - transdermal nicotine patch + bupropion

Behavioral: Tobacco quit line referral

Drug: Nicotine replacement therapy - nicotine lozenge

Drug: Varenicline

Drug: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum

Drug: Nicotine replacement therapy - transdermal nicotine patch

Drug: Nicotine replacement therapy - nicotine gum