Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
123 participants
INTERVENTIONAL
2016-12-31
2020-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tailored Intervention
The tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences.
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 activation for elevated depressive symptoms
Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
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.
Alcohol use risk reduction
Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
Nicotine replacement therapy - transdermal nicotine patch
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - nicotine lozenge
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - nicotine gum
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Bupropion sustained release
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Varenicline
Medication selection will be based on individual participant preferences, medical history, and contraindications.
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.
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.
Facilitated tobacco quit line referral
Participants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options.
Tobacco quit line
Referral to the Department of Veterans Affairs tobacco telephone quit line.
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,
Interventions
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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 activation for elevated depressive symptoms
Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
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.
Alcohol use risk reduction
Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
Nicotine replacement therapy - transdermal nicotine patch
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - nicotine lozenge
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - nicotine gum
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Bupropion sustained release
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Varenicline
Medication selection will be based on individual participant preferences, medical history, and contraindications.
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.
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.
Tobacco quit line
Referral to the Department of Veterans Affairs tobacco telephone quit line.
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,
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be willing to make a quit attempt in the next 30 days
3. Reside in a rural location
4. Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic
5. Able to provide informed consent
6. Telephone access
7. Stable residence
Exclusion Criteria
2. Terminal illness
3. Unstable psychiatric disorder
4. Incarcerated
5. Institutionalized
18 Years
99 Years
ALL
Yes
Sponsors
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Iowa City VA Health Care System
FED
Mark Vander Weg
FED
Responsible Party
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Mark Vander Weg
Reserach Specialist
Principal Investigators
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Mark W. Vander Weg, PhD
Role: PRINCIPAL_INVESTIGATOR
Iowa City VA Health Care System
Locations
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Iowa City VA Healthcare System
Iowa City, Iowa, United States
Countries
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Other Identifiers
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201611737
Identifier Type: -
Identifier Source: org_study_id
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