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Tobacco CessationAddictionMental healthBehavioralBehavioralDrugPhase 2, Phase 3

What this study is

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.

What's being tested

  • Tailored behavioral counseling

    Intervention · 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 · 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.

Study details

Sponsor
Iowa City Veterans Affairs Medical Center
Conditions
Tobacco Cessation
Enrolling
100 people
Starts
2020-09
Est. completion
2023-09
Design
Open-label, single group, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗