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Tailored Tobacco Quitline for Rural Veterans

This study has been completed.
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Mark Vander Weg, University of Iowa
ClinicalTrials.gov Identifier:
NCT01592695
First received: April 11, 2012
Last updated: June 20, 2017
Last verified: June 2017
  Purpose

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.

Condition Intervention Phase
Cigarette Smoking Drug: Nicotine replacement therapy - transdermal nicotine patch Behavioral: Tailored behavioral intervention 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 Behavioral: Alcohol use risk reduction Behavioral: Behavioral activation for the treatment of depression Behavioral: Behavioral management of post-cessation weight gain Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tailored Tobacco Cessation Program for Rural Veterans With Comorbid Depression, Alcoholism or Obesity

Resource links provided by NLM:


Further study details as provided by Mark Vander Weg, University of Iowa:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 63
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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
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.
Drug: Nicotine replacement therapy - transdermal nicotine patch
Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
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

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592695

Locations
United States, Iowa
Iowa City VA Health Care System
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
University of Iowa
VA Office of Research and Development
Investigators
Principal Investigator: Mark VanderWeg, PhD VRHRC-CR
  More Information

Publications:
Responsible Party: Mark Vander Weg, Research Specialist, University of Iowa
ClinicalTrials.gov Identifier: NCT01592695     History of Changes
Other Study ID Numbers: 201203712
Study First Received: April 11, 2012
Results First Received: April 14, 2017
Last Updated: June 20, 2017

Keywords provided by Mark Vander Weg, University of Iowa:
Nicotine dependence
Smoking cessation
Telehealth
Alcohol use
Depression
Body weight

Additional relevant MeSH terms:
Ethanol
Nicotine
Varenicline
Bupropion
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

ClinicalTrials.gov processed this record on September 25, 2017