Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

M

Mark Vander Weg

Status and phase

Unknown
Phase 3

Conditions

Nicotine Dependence
Tobacco Use

Treatments

Behavioral: Behavioral activation for depressive symptoms
Drug: Nicotine replacement therapy - Nicotine gum
Behavioral: Alcohol use risk reduction
Drug: Nicotine replacement therapy - Nicotine lozenge
Behavioral: Behavioral management of postcessation weight gain
Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Drug: Bupropion
Behavioral: Tobacco quitline referral
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Drug: Varenicline
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Drug: Nicotine replacement therapy - Transdermal nicotine patch
Behavioral: Tailored behavioral intervention

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01892813
201305740

Details and patient eligibility

About

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.

Enrollment

411 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

411 participants in 2 patient groups

Tailored intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Tailored behavioral intervention
Drug: Nicotine replacement therapy - Transdermal nicotine patch
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Drug: Varenicline
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Drug: Bupropion
Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Behavioral: Behavioral management of postcessation weight gain
Drug: Nicotine replacement therapy - Nicotine lozenge
Behavioral: Alcohol use risk reduction
Behavioral: Behavioral activation for depressive symptoms
Drug: Nicotine replacement therapy - Nicotine gum
Enhanced standard of care
Active Comparator group
Description:
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.
Treatment:
Drug: Nicotine replacement therapy - Transdermal nicotine patch
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum
Drug: Varenicline
Drug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge
Behavioral: Tobacco quitline referral
Drug: Bupropion
Drug: Combination pharmacotherapy - Transdermal nicotine patch + bupropion
Drug: Nicotine replacement therapy - Nicotine lozenge
Drug: Nicotine replacement therapy - Nicotine gum

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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