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: 1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users 2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
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.
Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
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.
Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
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.
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.
Referral to the Department of Veterans Affairs tobacco telephone quit line.
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,
Iowa City VA Healthcare System
Iowa City, Iowa, United States
Treatment satisfaction
Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.
Time frame: Three month follow-up
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.
Time frame: Three-and six-month follow-up
Alcohol use
Alcohol use during the previous seven days.
Time frame: Three- and six-month follow-up
Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)
Time frame: Three- and six-month follow-up
Body weight
Body weight will be assessed via self-report.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Three-month follow-up
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