A Stepped Care Approach to Treating Tobacco Use in Rural Veterans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tailored behavioral counseling, Tobacco cessation pharmacotherapy.
- Who it may be relevant to
- Registry conditions: Tobacco Cessation. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to augment the investigators' existing tailored tobacco treatment intervention.
Detailed description
Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of tobacco) from the Iowa City VA Health Care System will be proactively recruited using information obtained from the electronic medical record. All participants will receive the investigators' tailored, six session smoking cessation intervention developed over a series of projects funded by ORH. This includes a counseling protocol tailored to tobacco users' individual needs and associated risk factors as well as pharmacotherapy selected using shared decision making. Participants who are unable to quit initially will be provided with enhanced counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit using tobacco during the initial treatment phase will be given an extended, four-session counseling protocol that incorporates new content based on established interventions from positive psychology in an effort to reduce relapse.
Interventions
- Behavioral Tailored behavioral counseling
Participants will initially receive a six-session telephone intervention. Standard cognitive behavioral treatment strategies will be included. Participants will be screened for elevated depressive symptoms, risky alcohol use, and concerns about weight and and offered supplemental behavioral counseling related to these issues as appropriate. Those that are unable to quit tobacco initially will receive an enhanced, four-session counseling module focused on reduced scheduled smoking. Those who do q - Drug Tobacco cessation pharmacotherapy
Pharmacotherapy will be selected based on medical and psychiatric history and potential interactions with other current medications combined with shared decision making. Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily). Monotherapy and combination therapy options will be provided.
Primary outcome measures
- Tobacco cessation [Time frame: 6 months]
Secondary outcome measures (2)
- Tobacco cessation [Time frame: 3 months]
- Salivary cotinine levels (in ng/ml) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Use tobacco (cigarettes, smokeless tobacco, pipes, cigars, hookah) on a daily basis
- Be willing to make a quit attempt in the next 30 days
- Able to provide informed consent
- Have access to a telephone
- Have a stable residence,
Exclusion criteria
- Planning to move within the next 6 months
- Terminal illness
- Unstable psychiatric disorder (e.g., acute psychosis)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Iowa City VA Healthcare System — Iowa City
Identifiers
NCT: NCT04501016 · IowacityVAMC