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Tailored Tobacco Quitline for Rural Veterans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592695
First Posted: May 7, 2012
Last Update Posted: July 19, 2017
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.
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Mark Vander Weg, University of Iowa
April 11, 2012
May 7, 2012
April 14, 2017
July 19, 2017
July 19, 2017
June 2012
June 2013   (Final data collection date for primary outcome measure)
Treatment Satisfaction [ Time Frame: End of treatment (seven weeks after baseline) ]
Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.
Same as current
Complete list of historical versions of study NCT01592695 on ClinicalTrials.gov Archive Site
  • Number of Participants Abstinent From 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 days (point prevalence abstinence).
  • Alcohol Use [ Time Frame: Six-month follow-up ]
    Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.
  • Depressive Symptoms [ Time Frame: Six-month follow-up ]
    Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.
  • Body Weight [ Time Frame: Six-month follow-up ]
    Self-reported body weight.
  • Enrollment Rate [ Time Frame: 6 months after study initiation ]
    The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.
  • Retention [ Time Frame: End of treatment (seven weeks after baseline) ]
    The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.
  • Treatment Attendance [ Time Frame: End of treatment (seven weeks after baseline) ]
    The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.
  • 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 days (point prevalence abstinence) and any use of tobacco following an initial two-week grace period following the planned quit date (prolonged abstinence).
  • Alcohol Use [ Time Frame: Six-month follow-up ]
    Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module. 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.
  • Depressive Symptoms [ Time Frame: Six-month follow-up ]
    Depressive symptoms will be assessed among participants who receive the depression treatment using the Patient Health Questionnaire 9 (PHQ-9).
  • Body Weight [ Time Frame: Six-month follow-up ]
    Change in body weight following smoking cessation will be assessed via self-report and chart review among those receiving the weight management treatment module.
  • Enrollment Rate [ Time Frame: 6 months after study initiation ]
    The number of participants enrolled each month will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.
  • Retention [ Time Frame: End of treatment (seven weeks after baseline) ]
    The proportion of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.
  • Treatment Attendance [ Time Frame: End of treatment (seven weeks after baseline) ]
    The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.
Not Provided
Not Provided
 
Tailored Tobacco Quitline for Rural Veterans
Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity

The proposed work is designed to help increase access to tobacco cessation services among rural veterans and to develop more effective treatment services that better address comorbid issues commonly experienced by rural smokers. The objectives are:

  1. Study the feasibility of an individually-tailored telephone intervention for rural smokers.
  2. Examine the impact of the intervention on tobacco use outcomes.
  3. Evaluate the effect of the intervention on issues commonly experienced by rural smokers including depressive symptoms, alcohol use, and weight gain.

Tobacco use remains the leading preventable cause of morbidity and mortality in our society. Results from epidemiologic studies indicate that tobacco use is especially elevated among those living in rural areas. Although interventions exist that are both effective and cost-effective, few rural smokers utilize them during any given quit attempt. A lack of local treatment resources, the travel distance required to obtain treatment, and a reduced tendency to visit primary care on a regular basis all appear to contribute to the lower levels of treatment for nicotine dependence in rural smokers.

Smokers frequently experience conditions and concerns that adversely impact their ability to quit smoking. Depression and risky alcohol use, both of which are prevalent among smokers, reduce the likelihood of successfully quitting smoking. Concern about gaining weight, a common consequence of quitting smoking, is also frequently cited by smokers as an important barrier to quitting. Therefore, in order to be most effective, tobacco cessation interventions will need to address these important issues. Presently, treatment for nicotine dependence, risky alcohol use, depression, and weight management is typically delivered separately and without optimal integration among providers, an approach which only serves to fragment care and increase the number of required visits, further reduce rural smokers' access to care.

In an effort to address these barriers, the current study will evaluate a telephone intervention for tobacco use that also addresses issues related to risky alcohol use, depressed mood, and postcessation weight gain based on each individual smoker's needs. Results will provide valuable information regarding the potential to more widely implement an individually-tailored telephone intervention for rural smokers.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cigarette Smoking
  • Drug: Nicotine replacement therapy - transdermal nicotine patch
    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: Tobacco quit line referral
    Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
  • Drug: Nicotine replacement therapy - nicotine gum
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
  • Drug: Nicotine replacement therapy - nicotine lozenge
    Medication selection will be determined based on individual participant preferences, medical history, and contraindications
  • Drug: Bupropion Sustained Release
    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: Alcohol use risk reduction
    Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
    Other Names:
    • Risky alcohol use
    • Harm reduction
  • Behavioral: Behavioral activation for the treatment of depression
    Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
    Other Name: Depression
  • Behavioral: Behavioral management of post-cessation 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
  • Experimental: Tailored Intervention Group
    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 associated with cigarette smoking.
    Interventions:
    • Drug: Nicotine replacement therapy - transdermal nicotine patch
    • Behavioral: Tailored behavioral intervention
    • Drug: Nicotine replacement therapy - nicotine gum
    • Drug: Nicotine replacement therapy - nicotine lozenge
    • Drug: Bupropion Sustained Release
    • 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: Alcohol use risk reduction
    • Behavioral: Behavioral activation for the treatment of depression
    • Behavioral: Behavioral management of post-cessation weight gain
  • Active Comparator: Enhanced Standard of Care Group
    Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quit line along with pharmacotherapy to assist with smoking cessation.
    Interventions:
    • Drug: Nicotine replacement therapy - transdermal nicotine patch
    • Behavioral: Tobacco quit line referral
    • Drug: Nicotine replacement therapy - nicotine gum
    • Drug: Nicotine replacement therapy - nicotine lozenge
    • Drug: Bupropion Sustained Release
    • 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
Vander Weg MW, Cozad AJ, Howren MB, Cretzmeyer M, Scherubel M, Turvey C, Grant KM, Abrams TE, Katz DA. An individually-tailored smoking cessation intervention for rural Veterans: a pilot randomized trial. BMC Public Health. 2016 Aug 17;16(1):811. doi: 10.1186/s12889-016-3493-z.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Being a veteran
  • 18 + years of age
  • Smoke cigarettes on at least a daily basis
  • Receive primary care from the Iowa City VAMC or Coralville Clinic
  • Live in a non-metropolitan area (based on RUCA codes)
  • Be willing to make a quit attempt 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
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01592695
201203712
No
Not Provided
Not Provided
Mark Vander Weg, University of Iowa
University of Iowa
VA Office of Research and Development
Principal Investigator: Mark VanderWeg, PhD VRHRC-CR
University of Iowa
June 2017

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