Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

July 6, 2017 updated by: Mark Vander Weg

Tailored Tobacco Intervention

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
411

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • Iowa City VA Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
Drug: Nicotine replacement therapy - Transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Drug: Nicotine replacement therapy - Nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Other Names:
  • Nicotine polacrilix
Drug: Nicotine replacement therapy - Nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Other Names:
  • Nicotine polacrilix
Drug: Bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Other Names:
  • Zyban
Drug: Varenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Other Names:
  • Chantix
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion
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.
Behavioral: Alcohol use risk reduction
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
Other Names:
  • Harm reduction
Behavioral: Behavioral activation for depressive symptoms
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Behavioral: 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.
Other Names:
  • Weight management
Active Comparator: Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
Drug: Nicotine replacement therapy - Transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Drug: Nicotine replacement therapy - Nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Other Names:
  • Nicotine polacrilix
Drug: Nicotine replacement therapy - Nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Other Names:
  • Nicotine polacrilix
Drug: Bupropion
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Other Names:
  • Zyban
Drug: Varenicline
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Other Names:
  • Chantix
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 and 30 days.
Six-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alcohol use
Time Frame: Six-month follow-up
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
Depressive symptoms
Time Frame: Six-month follow-up
Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9).
Six-month follow-up
Body weight
Time Frame: Six-month follow-up
Change in body weight will be assessed via self-report and chart review at the six-month follow-up.
Six-month follow-up
Physical Activity
Time Frame: Six-month follow-up
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
Dietary intake
Time Frame: Six-month follow-up
Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire.
Six-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mark Vander Weg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark W. Vander Weg, Ph.D., VRHRC-CR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201305740

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings