Nicotine Dependence, Smokeless Tobacco
Conditions
Keywords
Rural health, Veterans, Smokeless tobacco cessation
Brief summary
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: 1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users 2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.
Interventions
BEHAVIORALTailored behavioral intervention
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.
BEHAVIORALBehavioral activation for elevated depressive symptoms
Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
BEHAVIORALPost-cessation weight gain management
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.
BEHAVIORALAlcohol use risk reduction
Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Medication selection will be based on individual participant preferences, medical history, and contraindications.
DRUGVarenicline
Medication selection will be based on individual participant preferences, medical history, and contraindications.
DRUGCombination nicotine replacement therapy
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.
DRUGCombination nicotine replacement therapy + bupropion
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.
BEHAVIORALTobacco quit line
Referral to the Department of Veterans Affairs tobacco telephone quit line.
BEHAVIORALEducational materials
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,
Sponsors
Iowa City VA Health Care System
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
1. Use smokeless tobacco on a daily basis 2. Be willing to make a quit attempt in the next 30 days 3. Reside in a rural location 4. Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic 5. Able to provide informed consent 6. Telephone access 7. Stable residence
Exclusion criteria
1. Planning to move in the next 12 months 2. Terminal illness 3. Unstable psychiatric disorder 4. Incarcerated 5. Institutionalized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment satisfaction | Three month follow-up | Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol use | Three- and six-month follow-up | Alcohol use during the previous seven days. |
| Depressive symptoms | Three- and six-month follow-up | Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9) |
| Body weight | Three- and six-month follow-up | Body weight will be assessed via self-report. |
| Tobacco use | Three-and six-month follow-up | 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. |
| Retention | Six months after study initiation | 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. |
| Treatment attendance | Three-month follow-up | 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. |
| Enrollment rate | Six months after study initiation | The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach. |
Countries
United States
Outcome results
None listed