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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04501016
Other study ID # IowacityVAMC
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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