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Clinical Trials/NCT04501016
NCT04501016
Not Yet Recruiting
Phase 2

A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Iowa City Veterans Affairs Medical Center1 site in 1 country100 target enrollmentSeptember 2020

Overview

Phase
Phase 2
Intervention
Tailored behavioral counseling
Conditions
Tobacco Cessation
Sponsor
Iowa City Veterans Affairs Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Tobacco cessation
Status
Not Yet Recruiting
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2020
End Date
September 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Iowa City Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Mark Vander Weg

Core Investigator

Iowa City Veterans Affairs Medical Center

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)

Arms & Interventions

Tailored Intervention

Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.

Intervention: Tailored behavioral counseling

Tailored Intervention

Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.

Intervention: Tobacco cessation pharmacotherapy

Outcomes

Primary Outcomes

Tobacco cessation

Time Frame: 6 months

7-day point prevalence tobacco cessation

Secondary Outcomes

  • Tobacco cessation(3 months)
  • Salivary cotinine levels (in ng/ml)(6 months)

Study Sites (1)

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