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Treating Smokeless Tobacco Use in Rural Veterans

Primary Purpose

Smokeless Tobacco, Nicotine Dependence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored behavioral intervention
Behavioral activation for elevated depressive symptoms
Post-cessation weight gain management
Alcohol use risk reduction
Nicotine replacement therapy - transdermal nicotine patch
Nicotine replacement therapy - nicotine lozenge
Nicotine replacement therapy - nicotine gum
Bupropion sustained release
Varenicline
Combination nicotine replacement therapy
Combination nicotine replacement therapy + bupropion
Tobacco quit line
Educational materials
Sponsored by
Mark Vander Weg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smokeless Tobacco focused on measuring Rural health, Veterans, Smokeless tobacco cessation

Eligibility Criteria

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

Inclusion Criteria:

  1. Use smokeless tobacco on a daily basis
  2. Be willing to make a quit attempt in the next 30 days
  3. Reside in a rural location
  4. Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic
  5. Able to provide informed consent
  6. Telephone access
  7. Stable residence

Exclusion Criteria:

  1. Planning to move in the next 12 months
  2. Terminal illness
  3. Unstable psychiatric disorder
  4. Incarcerated
  5. 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

Facilitated tobacco quit line referral

Arm Description

The tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences.

Participants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options.

Outcomes

Primary Outcome Measures

Treatment satisfaction
Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.

Secondary Outcome Measures

Tobacco use
At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use.
Alcohol use
Alcohol use during the previous seven days.
Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)
Body weight
Body weight will be assessed via self-report.
Enrollment rate
The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.
Retention
The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach.
Treatment attendance
The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach.

Full Information

First Posted
December 8, 2016
Last Updated
July 22, 2019
Sponsor
Mark Vander Weg
Collaborators
Iowa City VA Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT02994082
Brief Title
Treating Smokeless Tobacco Use in Rural Veterans
Official Title
Treating Smokeless Tobacco Use in Rural Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Vander Weg
Collaborators
Iowa City VA Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. The objectives are to: Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smokeless Tobacco, Nicotine Dependence
Keywords
Rural health, Veterans, Smokeless tobacco cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tailored Intervention
Arm Type
Experimental
Arm Description
The tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences.
Arm Title
Facilitated tobacco quit line referral
Arm Type
Active Comparator
Arm Description
Participants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options.
Intervention Type
Behavioral
Intervention Name(s)
Tailored behavioral intervention
Intervention Description
Participants will receive a standard six session cognitive behavioral intervention for smokeless tobacco cessation combined with supplemental treatment modules based on individual need and preferences.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral activation for elevated 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)
Post-cessation weight gain management
Intervention Description
Participants with concerns about gaining weight after quitting smokeless tobacco use may receive this six session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol use risk reduction
Intervention Description
Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
Intervention Type
Drug
Intervention Name(s)
Nicotine replacement therapy - transdermal nicotine patch
Other Intervention Name(s)
Nicotine patch
Intervention Description
Medication selection will be 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 lozenge
Intervention Description
Medication selection will be 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 gum
Intervention Description
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Bupropion sustained release
Other Intervention Name(s)
Zyban
Intervention Description
Medication selection will be 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 based on individual participant preferences, medical history, and contraindications.
Intervention Type
Drug
Intervention Name(s)
Combination nicotine replacement therapy
Intervention Description
Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.
Intervention Type
Drug
Intervention Name(s)
Combination nicotine replacement therapy + bupropion
Other Intervention Name(s)
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Intervention Description
Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.
Intervention Type
Behavioral
Intervention Name(s)
Tobacco quit line
Intervention Description
Referral to the Department of Veterans Affairs tobacco telephone quit line.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,
Primary Outcome Measure Information:
Title
Treatment satisfaction
Description
Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.
Time Frame
Three month follow-up
Secondary Outcome Measure Information:
Title
Tobacco use
Description
At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use.
Time Frame
Three-and six-month follow-up
Title
Alcohol use
Description
Alcohol use during the previous seven days.
Time Frame
Three- and six-month follow-up
Title
Depressive symptoms
Description
Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)
Time Frame
Three- and six-month follow-up
Title
Body weight
Description
Body weight will be assessed via self-report.
Time Frame
Three- and six-month follow-up
Title
Enrollment rate
Description
The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.
Time Frame
Six months after study initiation
Title
Retention
Description
The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach.
Time Frame
Six months after study initiation
Title
Treatment attendance
Description
The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach.
Time Frame
Three-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: Use smokeless tobacco on a daily basis Be willing to make a quit attempt in the next 30 days Reside in a rural location Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic Able to provide informed consent Telephone access Stable residence Exclusion Criteria: Planning to move in the next 12 months Terminal illness Unstable psychiatric disorder Incarcerated Institutionalized
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark W. Vander Weg, PhD
Organizational Affiliation
Iowa City VA Health Care System
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

Plan to Share IPD
No

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Treating Smokeless Tobacco Use in Rural Veterans

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