A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Study Overview
=================
Brief Summary
-----------------
Tobacco use remains prevalent among Veterans. Although effective smoking cessation interventions exist, long-term term quit rates remain sub-optimal. The project will investigate the feasibility of a stepped care approach to treating tobacco use that includes enhancements based on initial response to treatment to augment the investigators' existing tailored tobacco treatment intervention.

Detailed Description
-----------------
Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of tobacco) from the Iowa City VA Health Care System will be proactively recruited using information obtained from the electronic medical record. All participants will receive the investigators' tailored, six session smoking cessation intervention developed over a series of projects funded by ORH. This includes a counseling protocol tailored to tobacco users' individual needs and associated risk factors as well as pharmacotherapy selected using shared decision making. Participants who are unable to quit initially will be provided with enhanced counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit using tobacco during the initial treatment phase will be given an extended, four-session counseling protocol that incorporates new content based on established interventions from positive psychology in an effort to reduce relapse.

Official Title
-----------------
A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

Conditions
-----------------
Tobacco Cessation

Intervention / Treatment
-----------------
* Behavioral: Tailored behavioral counseling
* Drug: Tobacco cessation pharmacotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Use tobacco (cigarettes, smokeless tobacco, pipes, cigars, hookah) on a daily basis Be willing to make a quit attempt in the next 30 days Able to provide informed consent Have access to a telephone Have a stable residence, Exclusion Criteria: Planning to move within the next 6 months Terminal illness Unstable psychiatric disorder (e.g., acute psychosis)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All tobacco users will receive a tailored pharmacological and behavioral intervention. The specific counseling protocol will vary depending upon their response to treatment and initial success with quitting.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Intervention<br>Tailored behavioral counseling combined with tobacco cessation pharmacotherapy. | Behavioral: Tailored behavioral counseling<br>* Participants will initially receive a six-session telephone intervention. Standard cognitive behavioral treatment strategies will be included. Participants will be screened for elevated depressive symptoms, risky alcohol use, and concerns about weight and and offered supplemental behavioral counseling related to these issues as appropriate. Those that are unable to quit tobacco initially will receive an enhanced, four-session counseling module focused on reduced scheduled smoking. Those who do quit tobacco use initially will receive four sessions of extended counseling based on positive psychology intervention strategies.<br>Drug: Tobacco cessation pharmacotherapy<br>* Pharmacotherapy will be selected based on medical and psychiatric history and potential interactions with other current medications combined with shared decision making. Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily). Monotherapy and combination therapy options will be provided.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco cessation | 7-day point prevalence tobacco cessation | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco cessation | 7-day point prevalence tobacco cessation | 3 months | 
| Salivary cotinine levels (in ng/ml) | Salivary cotinine | 6 months |