Clinical trial NCT01592695
Conditions: Cigarette Smoking
Keywords: Nicotine dependence Smoking cessation Telehealth Alcohol use Depression Body weight
Sponsor: Iowa City Veterans Affairs Medical Center
Start date: 2012-06-01; Completion date: 2013-06-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Nicotine replacement therapy - transdermal nicotine patch intervention 2: Tailored behavioral intervention intervention 3: Tobacco quit line referral intervention 4: Nicotine replacement therapy - nicotine gum intervention 5: Nicotine replacement therapy - nicotine lozenge intervention 6: Bupropion Sustained Release intervention 7: Varenicline intervention 8: Combination pharmacotherapy - transdermal nicotine patch + nicotine gum intervention 9: Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge intervention 10: Combination pharmacotherapy - transdermal nicotine patch + bupropion intervention 11: Alcohol use risk reduction intervention 12: Behavioral activation for the treatment of depression intervention 13: Behavioral management of post-cessation weight gain
Intervention descriptions: intervention 1: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. intervention 2: Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference. intervention 3: 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. intervention 4: Medication selection will be determined based on individual participant preferences, medical history, and contraindications intervention 5: Medication selection will be determined based on individual participant preferences, medical history, and contraindications intervention 6: Medication selection will be determined based on individual participant preferences, medical history, and contraindications intervention 7: Medication selection will be determined based on individual participant preferences, medical history, and contraindications intervention 8: Medication selection will be determined based on individual participant preferences, medical history, and contraindications intervention 9: Medication selection will be determined based on individual participant preferences, medical history, and contraindications intervention 10: Medication selection will be determined based on individual participant preferences, medical history, and contraindications intervention 11: Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use. intervention 12: Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention. intervention 13: 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.

Protocol documents: