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OpenTrials
Completed

NCT Number: NCT01592695

Tailored Tobacco Quitline for Rural Veterans

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Iowa City VA Health Care System

Iowa City, Iowa, 52246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a veteran
  • 18 + years of age
  • Smoke cigarettes on at least a daily basis
  • Receive primary care from the Iowa City VAMC or Coralville Clinic
  • Live in a non-metropolitan area (based on RUCA codes)
  • Be willing to make a quit attempt in the next 30 days
  • Be capable of providing informed consent
  • Have access to a telephone (land line or cell phone)
  • Have a stable residence

Exclusion criteria

  • Planning to move within the next 12 months
  • Presence of a terminal illness
  • Pregnancy
  • Unstable psychiatric disorder (e.g., acute psychosis)
  • Currently pregnant
  • Incarcerated
  • Institutionalized

Treatment and study plan

Nicotine replacement therapy - transdermal nicotine patch

Drug

Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

Tailored behavioral intervention

Behavioral

Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.

Tobacco quit line referral

Behavioral

Participants 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.

Nicotine replacement therapy - nicotine gum

Drug

Medication selection will be determined based on individual participant preferences, medical history, and contraindications

Nicotine replacement therapy - nicotine lozenge

Drug

Medication selection will be determined based on individual participant preferences, medical history, and contraindications

Bupropion Sustained Release

Drug

Medication selection will be determined based on individual participant preferences, medical history, and contraindications

Other names: Zyban

Varenicline

Drug

Medication selection will be determined based on individual participant preferences, medical history, and contraindications

Other names: Chantix

Combination pharmacotherapy - transdermal nicotine patch + nicotine gum

Drug

Medication selection will be determined based on individual participant preferences, medical history, and contraindications

Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge

Drug

Medication selection will be determined based on individual participant preferences, medical history, and contraindications

Combination pharmacotherapy - transdermal nicotine patch + bupropion

Drug

Medication selection will be determined based on individual participant preferences, medical history, and contraindications

Alcohol use risk reduction

Behavioral

Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.

Other names: Risky alcohol use, Harm reduction

Behavioral activation for the treatment of depression

Behavioral

Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.

Other names: Depression

Behavioral management of post-cessation weight gain

Behavioral

Participants 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.

Other names: Weight management

Primary outcomes

  1. Treatment Satisfaction

    Time frame: End of treatment (seven weeks after baseline)

    Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.

Secondary outcomes

  1. Number of Participants Abstinent From Tobacco Use

    Time frame: Six-month follow-up

    At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).

  2. Alcohol Use

    Time frame: Six-month follow-up

    Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.

  3. Depressive Symptoms

    Time frame: Six-month follow-up

    Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.

  4. Body Weight

    Time frame: Six-month follow-up

    Self-reported body weight.

  5. Enrollment Rate

    Time frame: 6 months after study initiation

    The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.

  6. Retention

    Time frame: End of treatment (seven weeks after baseline)

    The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.

  7. Treatment Attendance

    Time frame: End of treatment (seven weeks after baseline)

    The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.

Sponsors and collaborators

Lead sponsor

Iowa City Veterans Affairs Medical Center

Fed

Collaborators

  • US Department of Veterans Affairs

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 7, 2012
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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