NCT02994082

Treating Smokeless Tobacco Use in Rural Veterans

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Mark Vander Weg · Federal
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Smokeless Tobacco
• Nicotine Dependence

Interventions

Type	Name	Description
BEHAVIORAL	Tailored behavioral intervention	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.
BEHAVIORAL	Behavioral activation for elevated depressive symptoms	Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
BEHAVIORAL	Post-cessation weight gain management	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.
BEHAVIORAL	Alcohol use risk reduction	Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
DRUG	Nicotine replacement therapy - transdermal nicotine patch	Medication selection will be based on individual participant preferences, medical history, and contraindications.
DRUG	Nicotine replacement therapy - nicotine lozenge	Medication selection will be based on individual participant preferences, medical history, and contraindications.
DRUG	Nicotine replacement therapy - nicotine gum	Medication selection will be based on individual participant preferences, medical history, and contraindications.
DRUG	Bupropion sustained release	Medication selection will be based on individual participant preferences, medical history, and contraindications.
DRUG	Varenicline	Medication selection will be based on individual participant preferences, medical history, and contraindications.
DRUG	Combination nicotine replacement therapy	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.
DRUG	Combination nicotine replacement therapy + bupropion	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.
BEHAVIORAL	Tobacco quit line	Referral to the Department of Veterans Affairs tobacco telephone quit line.
BEHAVIORAL	Educational materials	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,

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-09-01
• Completion: 2020-05-01
• First posted: 2016-12-15
• Last updated: 2019-07-24

Locations

1 site across 1 country: United States