Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored intervention | 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 (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference. |
|
| Enhanced standard of care | Active Comparator | 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. |
|
| 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 |
|---|---|---|
| Tobacco use | At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days. | Six-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol use | Alcohol use during the previous seven days will be assessed at the six month follow-up. Based on this information, several metrics of alcohol consumption will be obtained including: 1) average number of drinking days per week, 2) average number of drinks per drinking day, 3) number of drinks per week 4) number of heavy drinking days, and 5) maximum drinks consumed on a single occasion. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark W. Vander Weg, Ph.D. | VRHRC-CR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa City VA Healthcare System | Iowa City | Iowa | 52246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nicotine replacement therapy - Nicotine gum | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications. |
|
|
| Nicotine replacement therapy - Nicotine lozenge | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications. |
|
|
| Bupropion | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications. |
|
|
| Varenicline | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications. |
|
|
| Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications. |
|
| Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications. |
|
| Combination pharmacotherapy - Transdermal nicotine patch + bupropion | Drug | Medication selection will be determined based on individual participant preferences, medical history, and contraindications. |
|
| Tobacco quitline referral | Behavioral | 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 | 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. |
|
| Alcohol use risk reduction | Behavioral | Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use. |
|
|
| Behavioral activation for depressive symptoms | Behavioral | Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention. |
|
| Behavioral management of postcessation 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. |
|
|
| Six-month follow-up |
| Depressive symptoms | Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9). | Six-month follow-up |
| Body weight | Change in body weight will be assessed via self-report and chart review at the six-month follow-up. | Six-month follow-up |
| Physical Activity | Physical activity will be assessed by self-report at the six-month follow-up visit using the Rapid Assessment of Physical Activity (RAPA). | Six-month follow-up |
| Dietary intake | Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire. | Six-month follow-up |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D064424 | Tobacco Use |
| D016540 | Smoking Cessation |
| D000428 | Alcohol Drinking |
| D003863 | Depression |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D015438 | Health Behavior |
| D004327 | Drinking Behavior |
| D001526 | Behavioral Symptoms |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| 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 |
Not provided
Not provided