Nicotine Dependence Clinical Trial
Official title:
Treating Smokeless Tobacco Use in Rural Veterans
Verified date | July 2019 |
Source | Iowa City Veterans Affairs Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 123 |
Est. completion date | May 2020 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Iowa City VA Healthcare System | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Mark Vander Weg | Iowa City VA Health Care System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment satisfaction | Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview. | Three month follow-up | |
Secondary | 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 | |
Secondary | Alcohol use | Alcohol use during the previous seven days. | Three- and six-month follow-up | |
Secondary | Depressive symptoms | Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9) | Three- and six-month follow-up | |
Secondary | Body weight | Body weight will be assessed via self-report. | Three- and six-month follow-up | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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