Dissemination of a Tailored Tobacco Quitline for Rural Veteran Smokers

NCT01892813 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2017-07-11

No results posted yet for this study

Summary

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.

Conditions

  • Nicotine Dependence
  • Tobacco Use

Interventions

DRUG

Nicotine replacement therapy - Transdermal nicotine patch

Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

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

Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

DRUG

Varenicline

Medication selection will be determined based on individual participant preferences, medical history, and contraindications.

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

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.

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

Alcohol use risk reduction

Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.

BEHAVIORAL

Behavioral activation for depressive symptoms

Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.

BEHAVIORAL

Behavioral management of postcessation 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.

Sponsors & Collaborators

  • VA Office of Research and Development

    collaborator FED
  • Mark Vander Weg

    lead OTHER

Principal Investigators

  • Mark W. Vander Weg, Ph.D. · VRHRC-CR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01892813 on ClinicalTrials.gov