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Trial record 25 of 1349 for:    rural

Treating Smokeless Tobacco Use in Rural Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02994082
Recruitment Status : Active, not recruiting
First Posted : December 15, 2016
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Iowa City VA Health Care System
Information provided by (Responsible Party):
Mark Vander Weg, Iowa City Veterans Affairs Medical Center

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:

  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.

Condition or disease Intervention/treatment Phase
Smokeless Tobacco Nicotine Dependence 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Smokeless Tobacco Use in Rural Veterans
Study Start Date : December 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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 Name: Nicotine patch

Drug: Nicotine replacement therapy - nicotine lozenge
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Other Name: Nicotine lozenge

Drug: Nicotine replacement therapy - nicotine gum
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Other Name: Nicotine gum

Drug: Bupropion sustained release
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Other Name: Zyban

Drug: Varenicline
Medication selection will be based on individual participant preferences, medical history, and contraindications.
Other Name: 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 Name: 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,




Primary Outcome Measures :
  1. Treatment satisfaction [ Time Frame: Three month follow-up ]
    Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.


Secondary Outcome Measures :
  1. Tobacco use [ Time Frame: Three-and six-month follow-up ]
    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.

  2. Alcohol use [ Time Frame: Three- and six-month follow-up ]
    Alcohol use during the previous seven days.

  3. Depressive symptoms [ Time Frame: Three- and six-month follow-up ]
    Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)

  4. Body weight [ Time Frame: Three- and six-month follow-up ]
    Body weight will be assessed via self-report.

  5. Enrollment rate [ Time Frame: Six months after study initiation ]
    The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.

  6. Retention [ Time Frame: Six months after study initiation ]
    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.

  7. Treatment attendance [ Time Frame: Three-month follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994082


Locations
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United States, Iowa
Iowa City VA Healthcare System
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Mark Vander Weg
Iowa City VA Health Care System
Investigators
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Principal Investigator: Mark W. Vander Weg, PhD Iowa City VA Health Care System

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Responsible Party: Mark Vander Weg, Reserach Specialist, Iowa City Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02994082     History of Changes
Other Study ID Numbers: 201611737
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mark Vander Weg, Iowa City Veterans Affairs Medical Center:
Rural health
Veterans
Smokeless tobacco cessation
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Bupropion
Lobeline
Nicotine
Varenicline
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors