A Stepped Care Approach to Treating Tobacco Use in Rural Veterans

NCT04501016 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: IowacityVAMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Cessation

Outcome Measures

Primary Outcomes (1)

• Tobacco cessation

  7-day point prevalence tobacco cessation

  6 months

Secondary Outcomes (2)

• Tobacco cessation

  3 months

• Salivary cotinine levels (in ng/ml)

  6 months

Other Outcomes (1)

• Level of satisfaction with the intervention as measured according to a five-point scale (extremely, very, moderately, slightly, not at all)

  3 months

Study Arms (1)

Tailored Intervention

EXPERIMENTAL

Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.

Behavioral: Tailored behavioral counseling; Drug: Tobacco cessation pharmacotherapy

Interventions

Tailored behavioral counseling BEHAVIORAL

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.

Tailored Intervention

Tobacco cessation pharmacotherapy DRUG

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.

Tailored Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• Planning to move within the next 6 months
• Terminal illness
• Unstable psychiatric disorder (e.g., acute psychosis)

Sponsors & Collaborators

• Iowa City Veterans Affairs Medical Center: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Iowa City VA Healthcare System

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Mark Vander Weg, PhD

  Iowa City VA Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Morano, MS

CONTACT

319-338-0581; theresa.morano@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Core Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: September 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2023
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)