Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

Nicotine Dependence Clinical Trial

Official title:

Tailored Tobacco Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01892813
• Other study ID #: 201305740
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 1, 2013
• Last updated: July 6, 2017
• Start date: July 2013
• Est. completion date: January 2018

Study information

• Verified date: July 2017
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 411
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Veteran status

• 18 + years of age

• Smoke cigarettes on at least a daily basis

• Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC)

• Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes)

• Be willing to make an attempt to quit smoking 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

• Nicotine Dependence
• Tobacco Use
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine replacement therapy - Transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
• 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
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:
• Tobacco quitline referral
Participants assigned to this condition will receive a referral to their state tobacco quitline. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
• 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.
• 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 depressive symptoms
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
• Behavioral management of postcessation 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 Healthcare System	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Mark Vander Weg	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use	At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days.	Six-month follow-up
Secondary	Alcohol use	Alcohol use during the previous seven days will be assessed at the six month follow-up. Based on this information, several metrics of alcohol consumption will be obtained including: 1) average number of drinking days per week, 2) average number of drinks per drinking day, 3) number of drinks per week 4) number of heavy drinking days, and 5) maximum drinks consumed on a single occasion.	Six-month follow-up
Secondary	Depressive symptoms	Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9).	Six-month follow-up
Secondary	Body weight	Change in body weight will be assessed via self-report and chart review at the six-month follow-up.	Six-month follow-up
Secondary	Physical Activity	Physical activity will be assessed by self-report at the six-month follow-up visit using the Rapid Assessment of Physical Activity (RAPA).	Six-month follow-up
Secondary	Dietary intake	Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire.	Six-month follow-up