Nicotine Dependence, Tobacco Use
Conditions
Keywords
Nicotine dependence, Smoking cessation, Telehealth, Alcohol use, Depression, Body weight
Brief summary
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.
Interventions
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
DRUGBupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
DRUGVarenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
BEHAVIORALTobacco 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.
BEHAVIORALTailored 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.
BEHAVIORALAlcohol use risk reduction
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
BEHAVIORALBehavioral activation for depressive symptoms
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
BEHAVIORALBehavioral 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.
Sponsors
VA Office of Research and Development
Mark Vander Weg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Veteran status * 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
* Planning to move within the next 12 months * Presence of a terminal illness * Pregnancy * Unstable psychiatric disorder (e.g., acute psychosis) * Currently pregnant * Incarcerated * Institutionalized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco use | Six-month follow-up | At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol use | Six-month follow-up | 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. |
| Depressive symptoms | Six-month follow-up | Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9). |
| Body weight | Six-month follow-up | Change in body weight will be assessed via self-report and chart review at the six-month follow-up. |
| Physical Activity | Six-month follow-up | Physical activity will be assessed by self-report at the six-month follow-up visit using the Rapid Assessment of Physical Activity (RAPA). |
| Dietary intake | Six-month follow-up | Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire. |
Countries
United States
Outcome results
None listed