Treating Smokeless Tobacco Use in Rural Veterans

Nicotine Dependence Clinical Trial

Official title:

Treating Smokeless Tobacco Use in Rural Veterans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02994082
• Other study ID #: 201611737
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2016
• Est. completion date: May 2020

Study information

• Verified date: July 2019
• Source: Iowa City Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: May 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Use smokeless tobacco on a daily basis

2. Be willing to make a quit attempt in the next 30 days

3. Reside in a rural location

4. Receiving care through the Iowa City VA Health Care System or an affiliated community-based outpatient clinic

5. Able to provide informed consent

6. Telephone access

7. Stable residence

Exclusion Criteria:

1. Planning to move in the next 12 months

2. Terminal illness

3. Unstable psychiatric disorder

4. Incarcerated

5. Institutionalized

Related Conditions & MeSH terms

• Nicotine Dependence
• Smokeless Tobacco
• Tobacco Use Disorder

Intervention

Behavioral:
• Tailored behavioral intervention
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.
• Behavioral activation for elevated depressive symptoms
Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
• Post-cessation weight gain management
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.
• Alcohol use risk reduction
Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.

Drug:
• Nicotine replacement therapy - transdermal nicotine patch
Medication selection will be based on individual participant preferences, medical history, and contraindications.
• Nicotine replacement therapy - nicotine lozenge
Medication selection will be based on individual participant preferences, medical history, and contraindications.
• Nicotine replacement therapy - nicotine gum
Medication selection will be based on individual participant preferences, medical history, and contraindications.
• Bupropion sustained release
Medication selection will be based on individual participant preferences, medical history, and contraindications.
• Varenicline
Medication selection will be based on individual participant preferences, medical history, and contraindications.
• Combination nicotine replacement therapy
Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.
• Combination nicotine replacement therapy + bupropion
Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.

Behavioral:
• Tobacco quit line
Referral to the Department of Veterans Affairs tobacco telephone quit line.
• Educational materials
Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,

Locations

Country	Name	City	State
United States	Iowa City VA Healthcare System	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Mark Vander Weg	Iowa City VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment satisfaction	Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.	Three month follow-up
Secondary	Tobacco use	At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use.	Three-and six-month follow-up
Secondary	Alcohol use	Alcohol use during the previous seven days.	Three- and six-month follow-up
Secondary	Depressive symptoms	Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)	Three- and six-month follow-up
Secondary	Body weight	Body weight will be assessed via self-report.	Three- and six-month follow-up
Secondary	Enrollment rate	The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.	Six months after study initiation
Secondary	Retention	The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach.	Six months after study initiation
Secondary	Treatment attendance	The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach.	Three-month follow-up