Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2012-06-30
2013-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tailored Intervention Group
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.
Nicotine replacement therapy - transdermal nicotine patch
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.
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 Sustained Release
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
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 the treatment of depression
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Behavioral management of post-cessation 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 Group
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.
Nicotine replacement therapy - transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Tobacco quit line referral
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.
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 Sustained Release
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
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.
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.
Tobacco quit line referral
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.
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 Sustained Release
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
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 the treatment of depression
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Behavioral management of post-cessation 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 VAMC or Coralville Clinic
* Live in a non-metropolitan area (based on RUCA codes)
* Be willing to make a quit attempt 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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US Department of Veterans Affairs
FED
Iowa City Veterans Affairs Medical Center
FED
Responsible Party
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Mark Vander Weg
Research Specialist
Principal Investigators
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Mark VanderWeg, PhD
Role: PRINCIPAL_INVESTIGATOR
VRHRC-CR
Locations
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Iowa City VA Health Care System
Iowa City, Iowa, United States
Countries
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References
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Vander Weg MW, Cozad AJ, Howren MB, Cretzmeyer M, Scherubel M, Turvey C, Grant KM, Abrams TE, Katz DA. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial. BMC Public Health. 2016 Aug 17;16(1):811. doi: 10.1186/s12889-016-3493-z.
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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201203712
Identifier Type: -
Identifier Source: org_study_id
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