Brief Summary

This is a pilot study designed in an effort to develop and improve access to effective treatments for tobacco use in rural Veterans using a tailored intervention approach. Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco users including elevated depressive symptoms, risky alcohol use, and concerns about weight gain. The objectives are to:

1.Evaluate the feasibility of an individually-tailored telephone intervention for rural smokeless tobacco users
2.Examine the impact of the intervention on treatment utilization, patient satisfaction, and smokeless tobacco cessation.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

123

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Dec 2016

Longer than P75 for not_applicable

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

3.4 years study duration

Study Start

First participant enrolled

December 1, 2016

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2016

Completed

7 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed

Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

December 8, 2016

Last Update Submit

July 22, 2019

Conditions

Smokeless Tobacco Nicotine Dependence

Keywords

Rural healthVeteransSmokeless tobacco cessation

Outcome Measures

Primary Outcomes (1)

Treatment satisfaction
Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.
Three month follow-up

Secondary Outcomes (7)

Tobacco use
Three-and six-month follow-up
Alcohol use
Three- and six-month follow-up
Depressive symptoms
Three- and six-month follow-up
Body weight
Three- and six-month follow-up
Enrollment rate
Six months after study initiation
+2 more secondary outcomes

Study Arms (2)

Tailored Intervention

EXPERIMENTAL

The tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences.

Behavioral: Tailored behavioral interventionBehavioral: Behavioral activation for elevated depressive symptomsBehavioral: Post-cessation weight gain managementBehavioral: Alcohol use risk reductionDrug: Nicotine replacement therapy - transdermal nicotine patchDrug: Nicotine replacement therapy - nicotine lozengeDrug: Nicotine replacement therapy - nicotine gumDrug: Bupropion sustained releaseDrug: VareniclineDrug: Combination nicotine replacement therapyDrug: Combination nicotine replacement therapy + bupropion

Facilitated tobacco quit line referral

ACTIVE COMPARATOR

Participants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options.

Behavioral: Tobacco quit lineBehavioral: Educational materials

Interventions

Tailored behavioral interventionBEHAVIORAL

Participants will receive a standard six session cognitive behavioral intervention for smokeless tobacco cessation combined with supplemental treatment modules based on individual need and preferences.

Tailored Intervention

Behavioral activation for elevated depressive symptomsBEHAVIORAL

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

Tailored Intervention

Post-cessation weight gain managementBEHAVIORAL

Participants with concerns about gaining weight after quitting smokeless tobacco use may receive this six session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.

Tailored Intervention

Alcohol use risk reductionBEHAVIORAL

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

Tailored Intervention

Nicotine replacement therapy - transdermal nicotine patchDRUG