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Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

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: NCT01892813
Recruitment Status : Unknown
Verified July 2017 by Mark Vander Weg, University of Iowa.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2013
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Mark Vander Weg, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Tobacco Use Drug: Nicotine replacement therapy - Transdermal nicotine patch Drug: Nicotine replacement therapy - Nicotine gum Drug: Nicotine replacement therapy - Nicotine lozenge Drug: Bupropion Drug: Varenicline Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion Behavioral: Tobacco quitline referral Behavioral: Tailored behavioral intervention Behavioral: Alcohol use risk reduction Behavioral: Behavioral activation for depressive symptoms Behavioral: Behavioral management of postcessation weight gain Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tailored Tobacco Intervention
Study Start Date : July 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Arm Intervention/treatment
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 Name: Nicotine polacrilix

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

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

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

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

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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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.



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:

  • 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

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): NCT01892813


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
VA Office of Research and Development
Investigators
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Principal Investigator: Mark W. Vander Weg, Ph.D. VRHRC-CR

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Responsible Party: Mark Vander Weg, Associate Professor of Internal Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT01892813    
Other Study ID Numbers: 201305740
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Keywords provided by Mark Vander Weg, University of Iowa:
Nicotine dependence
Smoking cessation
Telehealth
Alcohol use
Depression
Body weight
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Bupropion
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
Enzyme Inhibitors