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Trial record 25 of 1364 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

Tracking Information
First Submitted Date  ICMJE December 8, 2016
First Posted Date  ICMJE December 15, 2016
Last Update Posted Date July 24, 2019
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
Treatment satisfaction [ Time Frame: Three month follow-up ]
Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02994082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2016)
  • 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.
  • Alcohol use [ Time Frame: Three- and six-month follow-up ]
    Alcohol use during the previous seven days.
  • Depressive symptoms [ Time Frame: Three- and six-month follow-up ]
    Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)
  • Body weight [ Time Frame: Three- and six-month follow-up ]
    Body weight will be assessed via self-report.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treating Smokeless Tobacco Use in Rural Veterans
Official Title  ICMJE Treating Smokeless Tobacco Use in Rural Veterans
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Smokeless Tobacco
  • Nicotine Dependence
Intervention  ICMJE
  • 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.
  • 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,
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • Behavioral: Tobacco quit line
    • Behavioral: Educational materials
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 22, 2019)
123
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2016)
50
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02994082
Other Study ID Numbers  ICMJE 201611737
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark Vander Weg, Iowa City Veterans Affairs Medical Center
Study Sponsor  ICMJE Mark Vander Weg
Collaborators  ICMJE Iowa City VA Health Care System
Investigators  ICMJE
Principal Investigator: Mark W. Vander Weg, PhD Iowa City VA Health Care System
PRS Account Iowa City Veterans Affairs Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP