A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Tobacco Cessation Clinical Trial

— Stepped Care  

Official title:

A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04501016
• Other study ID #: IowacityVAMC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 2020
• Est. completion date: September 2023

Study information

• Verified date: August 2020
• Source: Iowa City Veterans Affairs Medical Center
• Contact: Theresa Morano, MS
• Phone: 319-338-0581
• Email: theresa.morano[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Tobacco Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Iowa City VA Healthcare System	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Iowa City Veterans Affairs Medical Center	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Tobacco cessation	7-day point prevalence tobacco cessation	6 months
Secondary	Tobacco cessation	7-day point prevalence tobacco cessation	3 months
Secondary	Salivary cotinine levels (in ng/ml)	Salivary cotinine	6 months