A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

NCT ID: NCT04501016

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2023-09-30

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.

Conditions

Tobacco Cessation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tailored Intervention

Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.

Group Type: EXPERIMENTAL

Tailored behavioral counseling

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Iowa City Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Mark Vander Weg

Core Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Vander Weg, PhD

Role: PRINCIPAL_INVESTIGATOR

Iowa City VA Health Care System

Locations

Iowa City VA Healthcare System

Iowa City, Iowa, United States

Countries

United States

Central Contacts

Theresa Morano, MS

Role: CONTACT

theresa.morano@va.gov

319-338-0581 ext. 63-7663

Other Identifiers

IowacityVAMC

Identifier Type: -

Identifier Source: org_study_id