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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Tailored behavioral counseling
BehavioralParticipants 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
DrugPharmacotherapy 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
Trial outcomes
Primary outcomes
Tobacco cessation
7-day point prevalence tobacco cessation
Secondary outcomes
Tobacco cessation
7-day point prevalence tobacco cessation
Salivary cotinine levels (in ng/ml)
Salivary cotinine
Other outcomes
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.
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: