Clinical trial NCT04501016: A Stepped Care Approach to Treating Tobacco Use in Rural Veterans
Official title: A Stepped Care Approach to Treating Tobacco Use in Rural Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Tobacco Cessation
Lead sponsor: Iowa City Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2020-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All tobacco users will receive a tailored pharmacological and behavioral intervention. The specific counseling protocol will vary depending upon their response to treatment and initial success with quitting.
Primary purpose: TREATMENT

Brief summary: 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.

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)

Primary outcomes:
measure: Tobacco cessation
timeFrame: 6 months
Secondary outcomes:
measure: Tobacco cessation
timeFrame: 3 months
measure: Salivary cotinine levels (in ng/ml)
timeFrame: 6 months
Other outcomes:
measure: Level of satisfaction with the intervention as measured according to a five-point scale (extremely, very, moderately, slightly, not at all)
timeFrame: 3 months
Locations:
city: Iowa City
country: United States
facility: Iowa City VA Healthcare System
state: Iowa
Study officials:
affiliation: Iowa City VA Health Care System
name: Mark Vander Weg, PhD
role: PRINCIPAL_INVESTIGATOR
References: