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Tailored Intervention for Smokeless Tobacco

N/A
Waitlist Available
Led By Mark W. Vander Weg, PhD
Research Sponsored by Mark Vander Weg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three- and six-month follow-up
Awards & highlights

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

Eligible Conditions
  • Smokeless Tobacco
  • Nicotine Addiction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and three-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment satisfaction
Secondary outcome measures
Alcohol use
Body weight
Depressive symptoms
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tailored InterventionExperimental Treatment11 Interventions
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.
Group II: Facilitated tobacco quit line referralActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tailored behavioral intervention
2012
Completed Phase 2
~70
Varenicline
FDA approved
Alcohol use risk reduction
2012
Completed Phase 2
~70
Nicotine
FDA approved
Nicotine
FDA approved
Nicotine
FDA approved

Find a Location

Who is running the clinical trial?

Mark Vander WegLead Sponsor
1 Previous Clinical Trials
411 Total Patients Enrolled
Iowa City VA Health Care SystemFED
3 Previous Clinical Trials
35,546 Total Patients Enrolled
Mark W. Vander Weg, PhDPrincipal InvestigatorIowa City VA Health Care System
1 Previous Clinical Trials
376 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Treating Smokeless Tobacco Use in Rural Veterans
Mark Vander Weg 2016. "Treating Smokeless Tobacco Use in Rural Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02994082.
All > Wellbutrin
~15 spots leftby Apr 2025
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