Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers
NCT ID: NCT01892813
Last Updated: 2017-07-11
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
PHASE3
411 participants
INTERVENTIONAL
2013-07-31
2018-01-31
Brief Summary
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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
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 (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
Nicotine replacement therapy - Transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - Nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - Nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Varenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Tailored behavioral intervention
Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
Alcohol use risk reduction
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
Behavioral activation for depressive symptoms
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Behavioral management of postcessation weight gain
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.
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
Nicotine replacement therapy - Transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - Nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - Nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Varenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Tobacco quitline referral
Participants assigned to this condition will receive a referral to their state tobacco quitline. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
Interventions
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Nicotine replacement therapy - Transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - Nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Nicotine replacement therapy - Nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Varenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Tobacco quitline referral
Participants assigned to this condition will receive a referral to their state tobacco quitline. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
Tailored behavioral intervention
Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
Alcohol use risk reduction
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
Behavioral activation for depressive symptoms
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Behavioral management of postcessation weight gain
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 + years of age
* Smoke cigarettes on at least a daily basis
* Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC)
* Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes)
* Be willing to make an attempt to quit smoking 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
* Presence of a terminal illness
* Pregnancy
* Unstable psychiatric disorder (e.g., acute psychosis)
* Currently pregnant
* Incarcerated
* Institutionalized
18 Years
99 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Mark Vander Weg
OTHER
Responsible Party
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Mark Vander Weg
Associate Professor of Internal Medicine
Principal Investigators
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Mark W. Vander Weg, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
VRHRC-CR
Locations
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Iowa City VA Healthcare System
Iowa City, Iowa, United States
Countries
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References
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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Other Identifiers
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201305740
Identifier Type: -
Identifier Source: org_study_id
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