Tailored Tobacco Quitline for Rural Veterans

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01592695
First received: April 11, 2012
Last updated: June 12, 2012
Last verified: June 2012
  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 quitline referral
Drug: Nicotine replacement therapy - nicotine gum
Drug: Nicotine replacement therapy - nicotine lozenge
Drug: Bupropion SR
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 University of Iowa:

Primary Outcome Measures:
  • Treatment satisfaction [ Time Frame: End of treatment (seven weeks after baseline) ] [ Designated as safety issue: No ]
    Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.


Secondary Outcome Measures:
  • Tobacco use [ Time Frame: Six-month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: September 2012 (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 SR
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 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.
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.
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 SR
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 and older
Genders Eligible for Study:   Both
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
Investigators
Principal Investigator: Mark VanderWeg, PhD VRHRC-CR
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01592695     History of Changes
Other Study ID Numbers: N32-FY12Q1-S1-P00005
Study First Received: April 11, 2012
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ethanol
Bupropion
Nicotine
Varenicline
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
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
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014