A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorIowa City Veterans Affairs Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Planning to move within the next 6 months

Terminal illness

Unstable psychiatric disorder (e.g., acute psychosis)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Tailored InterventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Tobacco cessation

7-day point prevalence tobacco cessation

Time frame
6 months

Secondary outcomes

1

Tobacco cessation

7-day point prevalence tobacco cessation

Time frame
3 months
2

Salivary cotinine levels (in ng/ml)

Salivary cotinine

Time frame
6 months

Other outcomes

1

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.

Time frame
3 months

Sponsors and contacts

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Iowa City Veterans Affairs Medical Center

Lead sponsor

US Department of Veterans Affairs

Collaborator

This trial is not recruiting at the moment. You can still explore other options: