Clinical Trials Directory

Trials / Completed

CompletedNCT01592695

Tailored Tobacco Quitline for Rural Veterans

Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Iowa City Veterans Affairs Medical Center · Federal
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Accepted

Summary

The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are: 1. Study the feasibility of an individually-tailored telephone intervention for rural smokers. 2. Examine the impact of the intervention on tobacco use outcomes. 3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.

Detailed description

Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers. Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care. In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.

Conditions

Interventions

TypeNameDescription
DRUGNicotine replacement therapy - transdermal nicotine patchMedication selection will be determined based on individual participant preferences, medical history, and contraindications.
BEHAVIORALTailored behavioral interventionParticipants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
BEHAVIORALTobacco quit line referralParticipants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
DRUGNicotine replacement therapy - nicotine gumMedication selection will be determined based on individual participant preferences, medical history, and contraindications
DRUGNicotine replacement therapy - nicotine lozengeMedication selection will be determined based on individual participant preferences, medical history, and contraindications
DRUGBupropion Sustained ReleaseMedication selection will be determined based on individual participant preferences, medical history, and contraindications
DRUGVareniclineMedication selection will be determined based on individual participant preferences, medical history, and contraindications
DRUGCombination pharmacotherapy - transdermal nicotine patch + nicotine gumMedication selection will be determined based on individual participant preferences, medical history, and contraindications
DRUGCombination pharmacotherapy - transdermal nicotine patch + nicotine lozengeMedication selection will be determined based on individual participant preferences, medical history, and contraindications
DRUGCombination pharmacotherapy - transdermal nicotine patch + bupropionMedication selection will be determined based on individual participant preferences, medical history, and contraindications
BEHAVIORALAlcohol use risk reductionParticipants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
BEHAVIORALBehavioral activation for the treatment of depressionParticipants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
BEHAVIORALBehavioral management of post-cessation weight gainParticipants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.

Timeline

Start date
2012-06-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2012-05-07
Last updated
2019-08-02
Results posted
2017-07-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01592695. Inclusion in this directory is not an endorsement.