Treating Smokeless Tobacco Use in Rural Veterans

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:

1. Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users
2. Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.

Study Overview

• Status: Unknown
• Conditions: Nicotine Dependence; Smokeless Tobacco
• Intervention / Treatment: Behavioral: Tailored behavioral intervention; Behavioral: Behavioral activation for elevated depressive symptoms; Behavioral: Post-cessation weight gain management; Behavioral: Alcohol use risk reduction; Drug: Nicotine replacement therapy - transdermal nicotine patch; Drug: Nicotine replacement therapy - nicotine lozenge; Drug: Nicotine replacement therapy - nicotine gum; Drug: Bupropion sustained release; Drug: Varenicline; Drug: Combination nicotine replacement therapy; Drug: Combination nicotine replacement therapy + bupropion; Behavioral: Tobacco quit line; Behavioral: Educational materials

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored Intervention; 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.	Behavioral: Tailored behavioral intervention; 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.; Behavioral: Behavioral activation for elevated depressive symptoms; Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.; Behavioral: Post-cessation weight gain management; 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.; Behavioral: Alcohol use risk reduction; Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.; Drug: Nicotine replacement therapy - transdermal nicotine patch; Medication selection will be based on individual participant preferences, medical history, and contraindications.; Other Names: Nicotine patch; Drug: Nicotine replacement therapy - nicotine lozenge; Medication selection will be based on individual participant preferences, medical history, and contraindications.; Other Names: Nicotine lozenge; Drug: Nicotine replacement therapy - nicotine gum; Medication selection will be based on individual participant preferences, medical history, and contraindications.; Other Names: Nicotine gum; Drug: Bupropion sustained release; Medication selection will be based on individual participant preferences, medical history, and contraindications.; Other Names: Zyban; Drug: Varenicline; Medication selection will be based on individual participant preferences, medical history, and contraindications.; Other Names: Chantix; Drug: Combination nicotine replacement therapy; 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.; Drug: Combination nicotine replacement therapy + bupropion; 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.; Other Names: Medication selection will be based on individual participant preferences, medical history, and contraindications.
Active Comparator: Facilitated tobacco quit line referral; 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.	Behavioral: Tobacco quit line; Referral to the Department of Veterans Affairs tobacco telephone quit line.; Behavioral: Educational materials; 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment satisfaction	Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.	Three month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three-and six-month follow-up
Alcohol use	Alcohol use during the previous seven days.	Three- and six-month follow-up
Depressive symptoms	Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)	Three- and six-month follow-up
Body weight	Body weight will be assessed via self-report.	Three- and six-month follow-up
Enrollment rate	The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.	Six months after study initiation
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.	Six months after study initiation
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.	Three-month follow-up

Collaborators and Investigators

• Sponsor: Mark Vander Weg
• Collaborators: Iowa City VA Health Care System
• Investigators: Principal Investigator: Mark W. Vander Weg, PhD, Iowa City VA Health Care System

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Veterans; Rural health; Smokeless tobacco cessation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Nicotine; Bupropion; Varenicline
• Other Study ID Numbers: 201611737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No