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Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

Primary Purpose

Nicotine Dependence, Tobacco Use

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nicotine replacement therapy - Transdermal nicotine patch
Nicotine replacement therapy - Nicotine gum
Nicotine replacement therapy - Nicotine lozenge
Bupropion
Varenicline
Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Tobacco quitline referral
Tailored behavioral intervention
Alcohol use risk reduction
Behavioral activation for depressive symptoms
Behavioral management of postcessation weight gain
Sponsored by
Mark Vander Weg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine dependence, Smoking cessation, Telehealth, Alcohol use, Depression, Body weight

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Iowa City VA Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tailored intervention

Enhanced standard of care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Depressive symptoms
Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9).
Body weight
Change in body weight will be assessed via self-report and chart review at the six-month follow-up.
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).
Dietary intake
Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire.

Full Information

First Posted
July 1, 2013
Last Updated
July 6, 2017
Sponsor
Mark Vander Weg
Collaborators
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01892813
Brief Title
Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers
Official Title
Tailored Tobacco Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Vander Weg
Collaborators
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Tobacco Use
Keywords
Nicotine dependence, Smoking cessation, Telehealth, Alcohol use, Depression, Body weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
411 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced standard of care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine replacement therapy - Transdermal nicotine patch
Intervention Description
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Nicotine replacement therapy - Nicotine gum
Other Intervention Name(s)
Nicotine polacrilix
Intervention Description
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Nicotine replacement therapy - Nicotine lozenge
Other Intervention Name(s)
Nicotine polacrilix
Intervention Description
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Zyban
Intervention Description
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Intervention Description
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Intervention Description
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Intervention Description
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
Intervention Type
Behavioral
Intervention Name(s)
Tobacco quitline referral
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tailored behavioral intervention
Intervention Description
Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol use risk reduction
Other Intervention Name(s)
Harm reduction
Intervention Description
Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral activation for depressive symptoms
Intervention Description
Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral management of postcessation weight gain
Other Intervention Name(s)
Weight management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tobacco use
Description
At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days.
Time Frame
Six-month follow-up
Secondary Outcome Measure Information:
Title
Alcohol use
Description
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.
Time Frame
Six-month follow-up
Title
Depressive symptoms
Description
Depressive symptoms will be assessed at the six-month follow-up using the Patient Health Questionnaire 9 (PHQ-9).
Time Frame
Six-month follow-up
Title
Body weight
Description
Change in body weight will be assessed via self-report and chart review at the six-month follow-up.
Time Frame
Six-month follow-up
Title
Physical Activity
Description
Physical activity will be assessed by self-report at the six-month follow-up visit using the Rapid Assessment of Physical Activity (RAPA).
Time Frame
Six-month follow-up
Title
Dietary intake
Description
Self-reported dietary intake will be measured at six months using the Starting the Conversation - Diet questionnaire.
Time Frame
Six-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W. Vander Weg, Ph.D.
Organizational Affiliation
VRHRC-CR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa City VA Healthcare System
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

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