Tailored Tobacco Quitline for Rural Veterans

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592695
• Other study ID #: 201203712
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2019
• Source: Iowa City Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Drug:
• Nicotine replacement therapy - transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

Behavioral:
• Tailored behavioral intervention
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
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.

Drug:
• Nicotine replacement therapy - nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
• Nicotine replacement therapy - nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
• Bupropion Sustained Release
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
• Varenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
• Combination pharmacotherapy - transdermal nicotine patch + nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
• Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications
• Combination pharmacotherapy - transdermal nicotine patch + bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications

Behavioral:
• Alcohol use risk reduction
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
• Behavioral activation for the treatment of depression
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
• Behavioral management of post-cessation weight gain
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.

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Iowa City Veterans Affairs Medical Center	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vander Weg MW, Cozad AJ, Howren MB, Cretzmeyer M, Scherubel M, Turvey C, Grant KM, Abrams TE, Katz DA. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial. BMC Public Health. 2016 Aug 17;16(1):811. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Satisfaction	Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.	End of treatment (seven weeks after baseline)
Secondary	Number of Participants Abstinent From Tobacco Use	At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).	Six-month follow-up
Secondary	Alcohol Use	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.	Six-month follow-up
Secondary	Depressive Symptoms	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.	Six-month follow-up
Secondary	Body Weight	Self-reported body weight.	Six-month follow-up
Secondary	Enrollment Rate	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 months after study initiation
Secondary	Retention	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.	End of treatment (seven weeks after baseline)
Secondary	Treatment Attendance	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.	End of treatment (seven weeks after baseline)