A Stepped Care Approach to Treating Tobacco Use in Rural Veterans (Stepped Care)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Cessation
• Intervention / Treatment: Behavioral: Tailored behavioral counseling; Drug: Tobacco cessation pharmacotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Theresa Morano, MS; Phone Number: 63-7663 319-338-0581; Email: theresa.morano@va.gov

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52246
      • Iowa City VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tailored Intervention; Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco cessation	7-day point prevalence tobacco cessation	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco cessation	7-day point prevalence tobacco cessation	3 months
Salivary cotinine levels (in ng/ml)	Salivary cotinine	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of satisfaction with the intervention as measured according to a five-point scale (extremely, very, moderately, slightly, not at all)	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.	3 months

Collaborators and Investigators

• Sponsor: Iowa City Veterans Affairs Medical Center
• Collaborators: US Department of Veterans Affairs
• Investigators: Principal Investigator: Mark Vander Weg, PhD, Iowa City VA Health Care System

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 2, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IowacityVAMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No