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| Name | Class |
|---|---|
| Iowa City VA Health Care System | FED |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Intervention | Experimental | 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. |
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| Facilitated tobacco quit line referral | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored behavioral intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction | Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview. | Three month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco use | At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use. | Three-and six-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark W. Vander Weg, PhD | Iowa City VA Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa City VA Healthcare System | Iowa City | Iowa | 52246 | United States |
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| Behavioral activation for elevated depressive symptoms | Behavioral | Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention. |
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| Post-cessation weight gain management | Behavioral | 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. |
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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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| Nicotine replacement therapy - transdermal nicotine patch | Drug | Medication selection will be based on individual participant preferences, medical history, and contraindications. |
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| Nicotine replacement therapy - nicotine lozenge | Drug | Medication selection will be based on individual participant preferences, medical history, and contraindications. |
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| Nicotine replacement therapy - nicotine gum | Drug | Medication selection will be based on individual participant preferences, medical history, and contraindications. |
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| Bupropion sustained release | Drug | Medication selection will be based on individual participant preferences, medical history, and contraindications. |
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| Varenicline | Drug | Medication selection will be based on individual participant preferences, medical history, and contraindications. |
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| Combination nicotine replacement therapy | Drug | 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. |
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| Combination nicotine replacement therapy + bupropion | Drug | 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. |
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| Tobacco quit line | Behavioral | Referral to the Department of Veterans Affairs tobacco telephone quit line. |
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| Educational materials | Behavioral | 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, |
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| Alcohol use | Alcohol use during the previous seven days. | Three- and six-month follow-up |
| Depressive symptoms | Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9) | Three- and six-month follow-up |
| Body weight | Body weight will be assessed via self-report. | Three- and six-month follow-up |
| Enrollment rate | The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach. | Six months after study initiation |
| Retention | The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach. | Six months after study initiation |
| Treatment attendance | The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach. | Three-month follow-up |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D014029 | Tobacco Use Disorder |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| D016642 | Bupropion |
| D000068580 | Varenicline |
| D055991 | Health Records, Personal |
| D000075202 | Contraindications |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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