Tailored Tobacco Quitline for Rural Veterans

Phase 2

Completed

Conditions: Cigarette Smoking

Interventions: 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

Registration Number: NCT01592695

Lead Sponsor: Iowa City Veterans Affairs Medical Center

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored Intervention Group	Bupropion Sustained Release	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.
Enhanced Standard of Care Group	Bupropion Sustained Release	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.
Tailored Intervention Group	Nicotine replacement therapy - nicotine lozenge	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.
Tailored Intervention Group	Nicotine replacement therapy - transdermal nicotine patch	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.
Enhanced Standard of Care Group	Nicotine replacement therapy - transdermal nicotine patch	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.
Tailored Intervention Group	Tailored behavioral 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 associated with cigarette smoking.
Tailored Intervention Group	Nicotine replacement therapy - nicotine gum	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.
Tailored Intervention Group	Behavioral activation for the treatment of depression	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.
Enhanced Standard of Care Group	Nicotine replacement therapy - nicotine lozenge	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.
Enhanced Standard of Care Group	Combination pharmacotherapy - transdermal nicotine patch + bupropion	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.
Enhanced Standard of Care Group	Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge	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.
Tailored Intervention Group	Combination pharmacotherapy - transdermal nicotine patch + bupropion	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.
Tailored Intervention Group	Alcohol use risk reduction	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.
Tailored Intervention Group	Combination pharmacotherapy - transdermal nicotine patch + nicotine gum	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.
Tailored Intervention Group	Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge	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.
Enhanced Standard of Care Group	Nicotine replacement therapy - nicotine gum	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.
Enhanced Standard of Care Group	Combination pharmacotherapy - transdermal nicotine patch + nicotine gum	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.
Tailored Intervention Group	Behavioral management of post-cessation weight gain	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.
Enhanced Standard of Care Group	Tobacco quit line referral	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.
Tailored Intervention Group	Varenicline	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.
Enhanced Standard of Care Group	Varenicline	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.

Primary Outcome Measures

Name	Time	Method
Treatment Satisfaction	End of treatment (seven weeks after baseline)	Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.

Secondary Outcome Measures

Name	Time	Method
Enrollment Rate	6 months after study initiation	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.
Retention	End of treatment (seven weeks after baseline)	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.
Treatment Attendance	End of treatment (seven weeks after baseline)	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.
Number of Participants Abstinent From Tobacco Use	Six-month follow-up	At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).
Alcohol Use	Six-month follow-up	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.
Depressive Symptoms	Six-month follow-up	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.
Body Weight	Six-month follow-up	Self-reported body weight.