A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Iowa City Veterans Affairs Medical Center
Study ID
NCT04501016
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Tobacco Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Tailored behavioral counseling — 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 — 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

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.

Key Dates

Start date
Sep 30, 2020
Status verified
Aug 2020
Primary completion
Aug 31, 2021
Completion
Sep 30, 2023

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Tobacco cessation [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Iowa City VA Healthcare SystemIowa CityIowa52246-

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By research site
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