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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:
Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Intervention Group | Experimental | 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. |
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| Enhanced Standard of Care Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine replacement therapy - transdermal nicotine patch | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction | Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment. | End of treatment (seven weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Abstinent From Tobacco Use | At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence). | Six-month follow-up |
| Alcohol Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark VanderWeg, PhD | VRHRC-CR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa City VA Health Care System | Iowa City | Iowa | 52246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27535024 | Result | 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. | |
| 37142273 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Intervention Group | Participants will receive a combined behavioral and pharmacological intervention. Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination. Tailored behavioral intervention: Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules treatment modules to address common issues associated with cigarette smoking based on individual need and preference. Individual treatment models address alcohol risk reduction, elevated depressive symptoms, and concerns about weight gain. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tailored behavioral intervention | Behavioral | Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference. |
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| Tobacco quit line referral | Behavioral | 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. |
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| Nicotine replacement therapy - nicotine gum | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications |
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| Nicotine replacement therapy - nicotine lozenge | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications |
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| Bupropion Sustained Release | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications |
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| Varenicline | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications |
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| Combination pharmacotherapy - transdermal nicotine patch + nicotine gum | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications |
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| Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications |
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| Combination pharmacotherapy - transdermal nicotine patch + bupropion | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications |
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| Alcohol use risk reduction | Behavioral | Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use. |
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| Behavioral activation for the treatment of depression | Behavioral | Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention. |
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| Behavioral management of post-cessation weight gain | Behavioral | 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. |
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Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.
| Six-month follow-up |
| Depressive Symptoms | Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms. | Six-month follow-up |
| Body Weight | Self-reported body weight. | Six-month follow-up |
| Enrollment Rate | The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period. | 6 months after study initiation |
| Retention | The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach. | End of treatment (seven weeks after baseline) |
| Treatment Attendance | The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach. | End of treatment (seven weeks after baseline) |
| FG001 | 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. Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination. 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Intervention Group | Participants will receive a combined behavioral and pharmacological intervention. Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination. |
| BG001 | 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. Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Nicotine dependence | Possible scores range from 0 to 11. Higher scores indicate greater levels of nicotine dependence. | Mean | Standard Deviation | units on a scale |
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| Cigarettes smoked per day | Mean | Standard Deviation | cigarettes/day |
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| Prior quit attempts lasting at least 24 hours | Mean | Standard Deviation | quit attempts |
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| Readiness to quit smoking | Scores range from 1 to 10, with higher scores indicating greater readiness to quit smoking. | Mean | Standard Deviation | units on a scale |
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| Age of smoking initiation | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Satisfaction | Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment. | Participants who completed treatment satisfaction items on three-month follow-up | Posted | Count of Participants | Participants | End of treatment (seven weeks after baseline) |
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| Secondary | Number of Participants Abstinent From Tobacco Use | At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence). | 7-day point prevalence abstinence at 6 months. Those with missing data treated as smokers (penalized imputation). | Posted | Count of Participants | Participants | Six-month follow-up |
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| Secondary | Alcohol Use | Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group. | Participants in the tailored intervention group who received the alcohol intervention and those in the enhanced standard of care group who would have been eligible for the alcohol intervention if they had been assigned to the tailored intervention group. | Posted | Mean | Standard Deviation | Drinks consumed per day | Six-month follow-up |
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| Secondary | Depressive Symptoms | Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms. | Participants in the tailored intervention group who receive the mood management module and those in the enhanced standard of care condition who would have been eligible for the mood management module if they had been assigned to the tailored intervention condition. | Posted | Mean | Standard Deviation | units on a scale | Six-month follow-up |
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| Secondary | Body Weight | Self-reported body weight. | Assessed among participants in the tailored intervention group who received the weight management module and those in the enhanced standard of care condition who would have been eligible for the weight management module if they had been assigned to the tailored intervention condition. | Posted | Mean | Standard Deviation | Pounds | Six-month follow-up |
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| Secondary | Enrollment Rate | The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period. | Total number of participants randomized to each treatment condition. | Posted | Count of Participants | Participants | 6 months after study initiation |
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| Secondary | Retention | The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach. | Participants assigned to the tailored intervention condition who completed the intervention calls. | Posted | Count of Participants | Participants | End of treatment (seven weeks after baseline) |
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| Secondary | Treatment Attendance | The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach. | Attendance rate (number of counseling calls completed out of 6) among those assigned to the tailored intervention condition. | Posted | Mean | Full Range | Calls | End of treatment (seven weeks after baseline) |
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Six months
Data regarding adverse events were collected via self-report and information provided in patients' electronic medical record.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored Intervention Group | Participants will receive a combined behavioral and pharmacological intervention. Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG001 | 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. Pharmacotherapy: Medication selection will be determined based on individual participant preferences, medical history, and contraindications. Options will include nicotine replacement therapy (nicotine patch, nicotine gum, nicotine lozenge), bupropion, or varenicline. Medications will be provided as mono-therapy or in combination. 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Vander Weg, PhD | University of Iowa | 319-338-0581 | 7717 | mark-vanderweg@uiowa.edu |
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| D000428 | Alcohol Drinking |
| D003863 | Depression |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D004327 | Drinking Behavior |
| D001526 | Behavioral Symptoms |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| D000068580 | Varenicline |
| D000074164 | Nicotine Chewing Gum |
| D061485 | Tobacco Use Cessation Devices |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000438 | Alcohols |
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| >=65 years |
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| Male |
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| Found medication to be very or extremely useful |
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| Found treatment to be very or extremely convenient |
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| Found treatment to be very or extremely difficult |
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| Liked that treatment was delivered by phone |
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