Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

411

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jul 2013

Typical duration for phase_3

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.5 years study duration

First Submitted

Initial submission to the registry

July 1, 2013

Completed

Same day until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed

Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

4.5 years

First QC Date

July 1, 2013

Last Update Submit

July 6, 2017

Conditions

Nicotine Dependence Tobacco Use

Keywords

Nicotine dependenceSmoking cessationTelehealthAlcohol useDepressionBody weight

Outcome Measures

Primary Outcomes (1)

Tobacco use
At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days.
Six-month follow-up

Secondary Outcomes (5)

Alcohol use
Six-month follow-up
Depressive symptoms
Six-month follow-up
Body weight
Six-month follow-up
Physical Activity
Six-month follow-up
Dietary intake
Six-month follow-up

Study Arms (2)

Tailored intervention

EXPERIMENTAL

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.

Drug: Nicotine replacement therapy - Transdermal nicotine patchDrug: Nicotine replacement therapy - Nicotine gumDrug: Nicotine replacement therapy - Nicotine lozengeDrug: BupropionDrug: VareniclineDrug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gumDrug: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozengeDrug: Combination pharmacotherapy - Transdermal nicotine patch + bupropionBehavioral: Tailored behavioral interventionBehavioral: Alcohol use risk reductionBehavioral: Behavioral activation for depressive symptomsBehavioral: Behavioral management of postcessation weight gain

Enhanced standard of care

ACTIVE COMPARATOR

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.