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NCT Number: NCT04501016

A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

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.

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Key information

Conditions

Tobacco Cessation Behavior Health Behavior Tobacco Use Cessation

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Iowa City VA Healthcare System

Iowa City, Iowa, 52246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tailored behavioral counseling

Behavioral

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 quit tobacco use initially will receive four sessions of extended counseling based on positive psychology intervention strategies.

Tobacco cessation pharmacotherapy

Drug

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 outcomes

  1. Tobacco cessation

    Time frame: 6 months

    7-day point prevalence tobacco cessation

Secondary outcomes

  1. Tobacco cessation

    Time frame: 3 months

    7-day point prevalence tobacco cessation

  2. Salivary cotinine levels (in ng/ml)

    Time frame: 6 months

    Salivary cotinine

Other outcomes

  1. Level of satisfaction with the intervention as measured according to a five-point scale (extremely, very, moderately, slightly, not at all)

    Time frame: 3 months

    Self-reported satisfaction with the intervention according to the dimensions of usefulness, convenience, difficulty, liking, and helpfulness using five response options (extremely, very, moderately, slightly, not at all) using a scale developed specifically for the project.

Study contacts

Contact information is provided by the study sponsor or research team.

Theresa Morano, MS

CONTACT

[email protected]

319-338-0581 ext. 63-7663

Sponsors and collaborators

Lead sponsor

Iowa City Veterans Affairs Medical Center

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Acronym: Stepped Care

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Aug 6, 2020
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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